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OMEGA LABORATORIES, INC.

USA · Mogadore

✓ Record-verifiedregistrations found in 1 markets

This company has registrations in United States — 1 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

16listed device types

Class I 3Class II 12Class III 0unclassified 1

plus 19 registration records and 9 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States19 registration records, 9 510(k), 0 PMA, 28 excluded

Brazil0 confirmed, 5 excluded

Saudi Arabia0 confirmed, 1 excluded

Canada0 confirmed, 5 excluded

Manufacturer names merged into this page: OMEGA LABORATORIES, INC. · Essilor Laboratories of America, Inc. dba Omega Northcreek Lab

FDA 510(k) clearances by year

12010

22011 · K103161

22012 · K122759

22013 · K131128

22015 · K142855

FDA listed device types

showing 8 of 16

Test, Methamphetamine, Employment And Insurance Testing, Exempt 1Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt 1Enzyme Immunoassay, Opiates 1Enzyme Immunoassay, Amphetamine 1Prescription Spectacle Lenses To Reduce The Progression Of Myopia 1Gas Chromatography, Methamphetamine 1Test, Cannabinoid, Employment And Insurance Testing, Exempt 1Test, Opiates, Employment And Insurance Testing, Exempt 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K142855	Omega Laboratories Hair Drug Screening Assay Methamphetamine (Meth) and -3, 4-methylenedioxymethamphetamine (MDMA)	2015-07-28
US	K140671	OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR OPIATES, OXYCODONE AND HYDROCODONE	2015-01-08
US	K131128	OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR COCAINE AND COCAINE METABOLITES	2013-11-13

OMEGA LABORATORIES, INC.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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