Randox Laboratories, Ltd. - FDA 510(k) Cleared Devices

Cleared Feb 15, 1996

TOTAL CO2

K951221 · KHS

Chemistry · 332d

Cleared Dec 26, 1995

CK-MB (NAC-ACT)

K951223 · CGS

Chemistry · 281d

Cleared Dec 18, 1995

C-REACTIVE PROTEIN LATEX KIT

K954447 · DCK

Immunology · 84d

Cleared Sep 15, 1995

APOLIPOPROTEIN B IMMUNOTURBIDIEMETRIC KIT

K950382 · JHN

Chemistry · 227d

Cleared Sep 15, 1995

APOLIPOPROTEIN A-I IMMUNOTURBIDIMETRIC KIT

K950383 · JHN

Chemistry · 227d

Cleared Jul 31, 1995

C-REACTIVE PROTEIN IMMUNOTURBIDIMETRIC KIT & CRP CALIBRATOR

K953212 · DCK

Immunology · 21d

Cleared Mar 13, 1995

PRECISION-MULTI-SERA - HUMAN - NORMAL AND ELEVATED

K942458 · JJY

Chemistry · 293d

Cleared Jan 10, 1994

CHOLESTEROL ENZYMATIC ENDPOINT

K923504 · CHH

Chemistry · 544d

Cleared Sep 27, 1993

UREA KIT

K923506 · CDQ

Chemistry · 439d

Cleared Jul 28, 1993

TRIGLYCERIDES GPO-PAP

K923508 · CDT

Chemistry · 378d

Cleared Jul 22, 1993

URIC ACID ENZYMATIC COLORIMERIC KIT

K923503 · KNK

Chemistry · 372d

Cleared Dec 03, 1992

ALKALINE PHOSPHATASE KIT

K923507 · CJE

Chemistry · 141d

Cleared Dec 03, 1992

GAMMA-GT

K923509 · JPZ

Chemistry · 141d

Cleared Nov 16, 1992

AST (GOT) - ASPARTATE AMINOTRANSFERASE

K923505 · CIT

Chemistry · 124d

Cleared Nov 16, 1992

ALT (GPT) - ALANINE AMINOTRANSFERASE

K923510 · CKA

Chemistry · 124d

Cleared Oct 15, 1992

CK-NAC ACTIVATED KIT

K923511 · CGS

Chemistry · 92d