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
6913–6936 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jul 10, 1990
PRECIPATH(R) IM ABNORMAL IMMUNASSAY CONTROL SERUM
K902573 · JJY
Boehringer Mannheim Corp.
Chemistry · 33d
Cleared Jul 10, 1990
POTASSIUM REAGENT SET
K902574 · CEJ
Tech-Co, Inc.
Chemistry · 29d
Cleared Jul 10, 1990
ATAC 6000 CHEMISTRY ANALYZER
K902689 · JJE
Bio-Chem Laboratories
Chemistry · 21d
Cleared Jul 10, 1990
IMX ULTRASENTITIVE HTSH
K902753 · JLW
Abbott Mfg., Inc.
Chemistry · 18d
Cleared Jul 05, 1990
MODIFIED APSARA CLINICAL DIAGNOSTIC ANALYZER
K900788 · CEM
Datachem, Inc.
Chemistry · 135d
Cleared Jul 05, 1990
TECHNICON IMMUNO I(TM) SYSTEM AND ANALYTES
K902243 · KLS
Technicon Instruments Corp.
Chemistry · 48d
Cleared Jul 05, 1990
OPUS TSH TEST SYSTEM
K902333 · JLW
Pb Diagnostic Systems, Inc.
Chemistry · 42d
Cleared Jun 28, 1990
DIABETES CARE(TM) TEST PACKAGE FOR THE CLC 330(TM)
K896582 · LCP
Primus, Inc.
Chemistry · 223d
Cleared Jun 28, 1990
IONOMETER EH
K901039 · CEM
Fresenius USA, Inc.
Chemistry · 114d
Cleared Jun 28, 1990
COAT-A-COUNT PAP IRMA, CATLOG# 1KPA1, 1KPA2
K901933 · JFH
Diagnostic Products Corp.
Chemistry · 59d
Cleared Jun 28, 1990
KODAK SURECELL(TM) HCG-URINE TEST KIT
K902136 · JHI
Eastman Kodak Company
Chemistry · 49d
Cleared Jun 28, 1990
COULTER CREATININE REAGENT
K902172 · CGX
Coulter Corp.
Chemistry · 45d
Cleared Jun 28, 1990
HI CHEM ENZYME LINEARITY STANDARDS (PROD. 88235)
K902321 · JJT
Hichem Diagnostics
Chemistry · 36d
Cleared Jun 28, 1990
SYNERMED TOTAL BILIRUBIN REAGENT KIT
K902328 · CIG
Synermed, Inc.
Chemistry · 35d
Cleared Jun 28, 1990
CIBA CORNING MAGIC LITE LH IMMUNOASSAY
K902398 · CEP
Ciba Corning Diagnostics Corp.
Chemistry · 29d
Cleared Jun 26, 1990
COBAS READY PROFILE 2 REAGENT STRIP
K896225 · KNK
Roche Diagnostic Systems, Inc.
Chemistry · 239d
Cleared Jun 26, 1990
COBAS READY CALIBRATOR KIT
K897097 · JIX
Roche Diagnostic Systems, Inc.
Chemistry · 187d
Cleared Jun 20, 1990
CLINICAL ASSAYS(TM) GAMMACOAT(TM) M [125I] T4
K901475 · CDX
Baxter Healthcare Corp
Chemistry · 85d
Cleared Jun 18, 1990
J&S HDL CHOLESTEROL PRECIPITATING REAGENT
K900218 · LBL
J.S. Medical Assoc.
Chemistry · 152d
Cleared Jun 18, 1990
IONOMETER EH-HK AND ACCESSORIES
K901041 · CEM
Fresenius USA, Inc.
Chemistry · 104d
Cleared Jun 18, 1990
WAKO(TM) MICRO-ALBUMIN
K902216 · JIQ
Wako Chemicals USA, Inc.
Chemistry · 33d
Cleared Jun 18, 1990
CIBA CORNING ACS:180 AUTOMATED CHEMILUMINESCENCE
K902336 · JJE
Ciba Corning Diagnostics Corp.
Chemistry · 25d
Cleared Jun 18, 1990
MODIFIED DELFIA ESTRADIOL KIT
K902358 · CHP
Pharmacia, Inc.
Chemistry · 20d
Cleared Jun 12, 1990
SATELLITE C BLOOD CHOLESTEROL MONITORING SYSTEM
K896467 · CHH
Medisense, Inc.
Chemistry · 211d