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Carolina Liquid Chemistries Corporation

USA · Brea

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Canada, Russia — 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

57listed device types

Class I 17Class II 39Class III 0unclassified 1

plus 74 registration records and 21 510(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

3 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

1active registrations

Class 1 1

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 States74 registration records, 21 510(k), 0 PMA

Manufacturer names merged into this page: Carolina Liquid Chemistries · CAROLINA LIQUID CHEMISTRIES, CORP.

FDA 510(k) clearances by year

171997 · K971907

22014 · K133519

12017 · K163570

12022 · K213211

FDA listed device types

showing 8 of 57

Enzyme Immunoassay, Opiates 1Enzyme Immunoassay, Benzodiazepine 1Alkaline Picrate, Colorimetry, Creatinine 1Calibrator, Secondary 1Bromcresol Purple Dye-Binding, Albumin 1Calibrator, Primary 1Electrode, Ion-Specific, Chloride 1Ph Rate Measurement, Carbon-Dioxide 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K213211	Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM) Test System	2022-01-27
US	K163570	Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM)	2017-08-15
US	K133519	CAROLINA LIQUID CHEMISTRIES CLC 6410 CHEMISTRY ANALYZER; CAROLINA LIQUID CHEMISTRIES GLUCOSE REAGENT, CAR	2014-05-16

Carolina Liquid Chemistries Corporation

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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