FDA 510(k) Searchable Database - Search 175,000+ Clearances

Cleared Dec 03, 1992

ONE TOUCH TEST STRIPS

K923544 · CGA

Lifescan, Inc.

Chemistry · 140d

Cleared Dec 03, 1992

SYNERMED ENZYMATIC CO2 REAGENT KIT

K924428 · KHS

Synermed, Inc.

Chemistry · 93d

Cleared Dec 03, 1992

OLYMPUS GLUCOSE REAGENT

K924601 · CFR

Olympus Corp.

Chemistry · 83d

Cleared Dec 03, 1992

DMI BLOOD GAS ANALYZER/CARTRIDGE

K924758 · CHL

Diamond Medical, Inc.

Chemistry · 71d

Cleared Dec 03, 1992

OLYMPUS TOTAL BILIRUBIN REAGENT

K924964 · CIG

Olympus Corp.

Chemistry · 64d

Cleared Dec 03, 1992

QUICKVUE ONE-STEP HCG TEST

K925435 · JHI

Quidel Corp.

Chemistry · 36d

Cleared Nov 30, 1992

DELFIA HTSH ULTRA KIT

K923401 · JLW

Wallac OY

Chemistry · 143d

Cleared Nov 30, 1992

TESTOSTERONE SEROZYME(TM) ENZYME IMMUNOASSAY

K924257 · CDZ

Serono-Baker Diagnostics, Inc.

Chemistry · 98d

Cleared Nov 30, 1992

OLYMPUS DIRECT BILIRUBIN REAGENT

K924963 · CIG

Olympus Corp.

Chemistry · 61d

Cleared Nov 30, 1992

VIDAS FREE THYROXINE(FT4) ASSAY

K925177 · CEC

Biomerieux Vitek, Inc.

Chemistry · 47d

Cleared Nov 25, 1992

MEDIX BIOTECH BESTEST(TM) HCG-URINE, CAT# B1H0100

K924259 · JHI

Medix Biotech, Inc.

Chemistry · 93d

Cleared Nov 25, 1992

EMDS GLUCOSE (GLU-HK) TEST, ITEM 65415

K924572 · CFR

Em Diagnostic Systems, Inc.

Chemistry · 76d

Cleared Nov 25, 1992

OLYMPUS BUN REAGENT

K924693 · CDQ

Olympus Corp.

Chemistry · 70d

Cleared Nov 25, 1992

TECHNICON CHEM 1(R)/CHEM 1+(TM) SOFTWARE VER 11.1

K925203 · JJQ

Heraeus Kulzer, Inc.

Chemistry · 97d

Cleared Nov 23, 1992

SYNCHRON TOTAL PROTEIN TEST --MODIFIED

K922467 · CEK

Beckman Instruments, Inc.

Chemistry · 193d

Cleared Nov 19, 1992

OLYMPUS INORGANIC PHOSPHORUS REAGENT

K925057 · CEO

Olympus Corp.

Chemistry · 44d

Cleared Nov 18, 1992

OLYMPUS CHOLESTEROL REAGENT

K922231 · CHH

Olympus Corp.

Chemistry · 190d

Cleared Nov 18, 1992

ROCHE REAGENT FOR GGT

K924246 · JQB

Roche Diagnostic Systems, Inc.

Chemistry · 86d

Cleared Nov 18, 1992

TSH - THIRD GENERATION LOW CONTROLS

K924675 · JJX

Nichols Institute

Chemistry · 63d

Cleared Nov 18, 1992

OLYMPUS ALKALINE PHOSPHATASE REAGENT

K925156 · CJE

Olympus Corp.

Chemistry · 36d

Cleared Nov 17, 1992

LUMICO ANALYZER SA-300

K923158 · JJQ

Maruzen Petrochemical Co., Ltd.

Chemistry · 141d

Cleared Nov 16, 1992

BERTHOLD LB 954

K922329 · JJQ

Eg&G Berthold Analytical Instruments,...

Chemistry · 188d

Cleared Nov 16, 1992

MULTIDRAW SYSTEM

K922858 · GIM

Cambridge Multi-Draw, Inc.

Chemistry · 154d

Cleared Nov 16, 1992

LB 9502- CLINILUMAT, LB 953 - AUTO-CLIMILUMAT

K922976 · JJQ

Eg&G Berthold Analytical Instruments,...

Chemistry · 171d