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

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Chemistry ×
13,237 results
8521–8544 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Feb 20, 1987
DOCUMENT(TM) MULTI-ANALYTE LINEARITY TEST SET
K870252 · JJY
Casco Standards
Chemistry · 30d
Cleared Feb 20, 1987
SALICYLATE ASSAY KIT, CATALOGUE NUMBER 501-71
K870336 · DKJ
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 23d
Cleared Feb 18, 1987
SERALYZER GLUCOSE (HK) REAGENT STRIPS,MODULE,CALI.
K864530 · CGA
Miles Laboratories, Inc.
Chemistry · 93d
Cleared Feb 18, 1987
SIMULTRAC FREE T4[57CO]/TSH MAB[125I]
K864838 · CEC
Bd Becton Dickinson Vacutainer...
Chemistry · 71d
Cleared Feb 18, 1987
SERA-TEK MICROSOMAL ANTIBODY TEST
K865053 · JZO
Miles Laboratories, Inc.
Chemistry · 56d
Cleared Feb 18, 1987
REFLOTRON(R) AST (GOT)
K870246 · CIT
Boehringer Mannheim Corp.
Chemistry · 28d
Cleared Feb 13, 1987
WAKO (TM) AUTOKIT GOT TEST
K864813 · CIT
Wako Chemicals USA, Inc.
Chemistry · 66d
Cleared Feb 13, 1987
ELECTRA AUTOMATIC SAMPLER
K864875 · JQW
Medical Laboratory Automation...
Chemistry · 63d
Cleared Feb 13, 1987
DU PONT LIQUID MULTI-ANALYTE CALIBRATOR
K864909 · JIX
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 60d
Cleared Feb 13, 1987
BICARBONATE PROCEDURE
K870062 · KHS
Data Medical Associates, Inc.
Chemistry · 37d
Cleared Feb 12, 1987
DART DIGOXIN ASSAY
K864802 · LCS
Coulter Electronics, Inc.
Chemistry · 65d
Cleared Feb 12, 1987
RAICHEM (TM)SERUM IRON AND TIBC REAGENTS
K864819 · JIY
Reagents Applications, Inc.
Chemistry · 65d
Cleared Feb 12, 1987
RAICHEM(TM) CREATININE REAGENT (ENZYMATIC)
K864992 · JFY
Reagents Applications, Inc.
Chemistry · 52d
Cleared Feb 11, 1987
SYNTRON BIORESEARCH MICROCHECK HCG PREGNANCY TEST
K865076 · JHI
Syntron Bioresearch, Inc.
Chemistry · 44d
Cleared Feb 11, 1987
AMMONIA (AMON) TESTPACK, ITEM NO. 67689/95
K870143 · JIF
Em Diagnostic Systems, Inc.
Chemistry · 29d
Cleared Feb 11, 1987
EMIT QUINIDINE CALIBRATOR ITEM NO. 67631/93
K870247 · DLJ
Em Diagnostic Systems, Inc.
Chemistry · 21d
Cleared Feb 06, 1987
DPC COAT-A-COUNT IRMA LH KIT
K863934 · CEP
Diagnostic Products Corp.
Chemistry · 120d
Cleared Feb 06, 1987
AST(GOT) (ASPARTATE AMINOTRANSFERASE) REAGENT
K864357 · CIT
Trace Scientific , Ltd.
Chemistry · 95d
Cleared Feb 06, 1987
CK-NAC REAGENT(CREATINE KINASE/N-ACETYL CYSTEINE)
K864359 · CGS
Trace Scientific , Ltd.
Chemistry · 95d
Cleared Feb 06, 1987
LDH-P (LACTIC DEHYDROGENASE) REAGENT - SCE
K864360
Trace Scientific , Ltd.
Chemistry · 95d
Cleared Feb 06, 1987
UV VISIBLE SPECTROPHOTOMETERS
K864451 · JJQ
Trans-National Trade Development Corp.
Chemistry · 86d
Cleared Feb 06, 1987
ARTEL DIFFERENTIAL PHOTOMETER
K864542 · JJQ
Artel, Inc.
Chemistry · 79d
Cleared Feb 04, 1987
UBI MAGIWEL(TM) LH QUANTITATIVE & QUALITATIVE
K863442 · CEP
United Biotech, Inc.
Chemistry · 152d
Cleared Feb 04, 1987
STAT PROFILE 4 ANALYZER + QUALITY CONTROL MATERIAL
K864445 · CHL
Nova Biomedical Corp.
Chemistry · 84d