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
7345–7368 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Aug 10, 1989
CYBERLAB HIGH VOLUME DRUG TESTING SYSTEM
K892060 · JQP
Syva Co.
Chemistry · 134d
Cleared Aug 10, 1989
EXCEL (TM) CHEMISTRY ANALYZER
K893137 · JJE
American Monitor Corp.
Chemistry · 107d
Cleared Aug 03, 1989
INTEGRA(TM) BLOOD GLUCOSE MONITORING SYSTEM
K893404 · CGA
Apprise, Inc.
Chemistry · 93d
Cleared Aug 03, 1989
CLINIMATE-TDA BLOOD CHEMISTRY ANALYZER
K893547 · JJE
Heraeus Kulzer, Inc.
Chemistry · 87d
Cleared Aug 03, 1989
SERALYZER HDL CHOLESTEROL PROCEDURE USE W/STRIP
K893548 · LBS
Heraeus Kulzer, Inc.
Chemistry · 87d
Cleared Aug 03, 1989
STATUS HCG FLUOROMETRIC ENZYME
K893577 · DHA
Baxter Healthcare Corp
Chemistry · 86d
Cleared Aug 03, 1989
ABBOTT ASSET AUTOMATED CLINICAL CHEMISTRY ANALYZER
K893776 · JJE
Abbott Laboratories
Chemistry · 73d
Cleared Aug 03, 1989
IMMUNO-WASH AUTOMATED TUBE WASHER
K893810 · JQW
Ocean Scientific, Inc.
Chemistry · 73d
Cleared Aug 03, 1989
COBAS FARA II CENTRIFUGAL ANALYZER
K893854 · JJG
Roche Diagnostic Systems, Inc.
Chemistry · 70d
Cleared Aug 03, 1989
AMERLEX-MAB FT4 KIT
K894091 · CEC
Amersham Corp.
Chemistry · 55d
Cleared Aug 03, 1989
QUALICHECK 2
K894110 · JJS
Radiometer America, Inc.
Chemistry · 52d
Cleared Aug 02, 1989
RAICHEM(TM) SPIA(TM) IGM REAGENTS
K894417 · DFT
Reagents Applications, Inc.
Chemistry · 16d
Cleared Aug 02, 1989
RAICHEM(TM) SPIA(TM) IGA REAGENTS
K894418 · CZP
Reagents Applications, Inc.
Chemistry · 16d
Cleared Aug 01, 1989
LYPHOCHEK(R) IMMUNOASSAY CONTR SERUM (HUMAN) 1,2,3
K891475 · JJX
Bio-Rad
Chemistry · 138d
Cleared Aug 01, 1989
RAICHEM(TM) SPIA(TM) IGG REAGENTS
K894416 · KTO
Reagents Applications, Inc.
Chemistry · 15d
Cleared Jul 27, 1989
TECHNICON DAX TM SYSTEM ADDITIONAL ANALYTES
K892930 · CKA
Technicon Instruments Corp.
Chemistry · 97d
Cleared Jul 27, 1989
CIBA CORNING MAGIC LITE FOLATE IMMUNOASSAY
K893684 · CGN
Ciba Corning Diagnostics Corp.
Chemistry · 72d
Cleared Jul 25, 1989
GENETIC SYSTEMS MICROPLATE READER
K891767 · JJQ
Genetic Systems Corp.
Chemistry · 123d
Cleared Jul 25, 1989
STANBIO ENZYMATIC UREA NITROGEN DETERMINAT #2010
K893128 · CDL
Stanbio Laboratory
Chemistry · 91d
Cleared Jul 25, 1989
DU PONT DIMENSION PSID CLINICAL CHEMISTRY SYSTEM
K893775 · JQW
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 64d
Cleared Jul 25, 1989
DAU I, DAU II, DAU III AND DAU IV CONTROL URINE
K893835 · DIF
Ciba Corning Diagnostics Corp.
Chemistry · 62d
Cleared Jul 25, 1989
HDL PRECIPITATING REAGENT
K893966 · LBR
Diagnostic Systems
Chemistry · 53d
Cleared Jul 25, 1989
MINICLINIC PREGNANCY TEST
K894012 · JHI
Vanguard Biomedical Corp.
Chemistry · 49d
Cleared Jul 20, 1989
STAT CHEM SYSTEM
K891050 · CGA
Diagnostic Resources, Inc.
Chemistry · 142d