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SYNTRON BIORESEARCH, INC.

USA · Carlsbad

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Canada, South Korea — 3 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

4listed device types

Class I 2Class II 2Class III 0

plus 6 registration records and 26 510(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

28 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

IVD import 1

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 States6 registration records, 26 510(k), 0 PMA

Manufacturer names merged into this page: SYNTRON BIORESEARCH, INC. · SYNTRON BIORESEARCH INC

FDA 510(k) clearances by year

41987

11991

11992

21993

41995

21996

11997

51998

61999

FDA listed device types

Test, Follicle Stimulating Hormone (Fsh), Over The Counter 1Test, Luteinizing Hormone (Lh), Over The Counter 1Kit, Test, Pregnancy, Hcg, Over The Counter 1Visual, Pregnancy Hcg, Prescription Use 1

Market	Identifier	Name	Class / date
US	K993490	QUICKSTRIP ONE STEP OPIATES TEST	1999-10-29
US	K993491	QUICKPAC II ONE STEP OPIATES TEST	1999-10-29
US	K992990	QUICKPAC II ONE STEP COCAINE TEST	1999-09-20

SYNTRON BIORESEARCH, 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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