FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Chemistry ×
13,231 results
11977–12000 of 13,231
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Mar 19, 1980
T3 SOLID PHASE RADIOIMMUNOASSAY KIT
K800436 · CDP
Bd Becton Dickinson Vacutainer...
Chemistry · 21d
Cleared Mar 12, 1980
CENTRIFICHEM FILTER CALIBRATION SET
K800304 · JIW
Union Carbide Corp.
Chemistry · 29d
Cleared Mar 12, 1980
BUN REAGENT
K800341 · CDQ
Gilford Diagnostics
Chemistry · 26d
Cleared Mar 12, 1980
CK/LD ISOENZYME CONTROL PROD. #ACS CT101
K800370 · JJY
Analytical Control Systems, Inc.
Chemistry · 21d
Cleared Mar 12, 1980
AMERLEX T-3 RIA KIT
K800374 · CDP
Amersham Corp.
Chemistry · 20d
Cleared Mar 05, 1980
DATA MANAGEMENT SYSTEM IL MODEL 775
K800282 · JQP
Instrumentation Laboratory CO
Chemistry · 26d
Cleared Mar 05, 1980
WHOLE BLOOD GAS CONTROL, LEVELS 1,2,&3
K800296 · GGM
Dade, Baxter Travenol Diagnostics, Inc.
Chemistry · 23d
Cleared Mar 05, 1980
SANDARE FAST 340 PHOSPHOROUS PROCEDURE
K800297 · CEO
Sandare Chemical Co., Inc.
Chemistry · 23d
Cleared Mar 05, 1980
AMERLEX T-4 RIA KIT
K800300 · CDX
Amersham Corp.
Chemistry · 23d
Cleared Mar 05, 1980
SIGMA PROCEDURE & REAGENT SYSTEM #335-UV
K800301 · CDT
Sigma Chemical Co.
Chemistry · 23d
Cleared Mar 03, 1980
FIAX TEST KIT FOR HERPES SIMPLEX VIRUS
K792559 · GQL
Intl. Diagnostic Technology
Chemistry · 83d
Cleared Mar 03, 1980
ACA CHOLESEROL/HDL CHOLESTEROL CALIBRAT.
K800206 · JIS
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 33d
Cleared Mar 03, 1980
MICRO MEDICAL DATA SYSTEM II
K800242 · JQP
Micro/Tel., Inc.
Chemistry · 27d
Cleared Mar 03, 1980
EMIT AUTO CORTISOL ASSAY
K800245 · CGR
Syva Co.
Chemistry · 27d
Cleared Feb 26, 1980
SODIUM/POTASSIUM CONDITIONING REAGENT
K800216 · JGS
Fisher Scientific Co., LLC
Chemistry · 22d
Cleared Feb 26, 1980
CHLORIDE REAGENT, CUP & CLEANER
K800217 · JFS
Fisher Scientific Co., LLC
Chemistry · 22d
Cleared Feb 26, 1980
CARBON DIOXIDE CUP REAGENT & REF.RGT.
K800218 · JFL
Fisher Scientific Co., LLC
Chemistry · 22d
Cleared Feb 26, 1980
SERUM CREATININE
K800219 · CGX
Fisher Scientific Co., LLC
Chemistry · 22d
Cleared Feb 26, 1980
CALIBRATOR NO. 1 & 2, & WASH SOLUTION
K800220 · JIT
Fisher Scientific Co., LLC
Chemistry · 22d
Cleared Feb 26, 1980
MICRO MEDICAL DATA SYSTEM
K800241 · JQP
Micro/Tel., Inc.
Chemistry · 21d
Cleared Feb 26, 1980
COROMETRICS MEDICAL SYSTEMS 220 PH SYS.
K800271 · CHL
Transidyne General Corp.
Chemistry · 20d
Cleared Feb 22, 1980
RADIOMETER ACID BASE LABORATORY-ABL-3
K800224 · CHL
The London Co.
Chemistry · 17d
Cleared Feb 21, 1980
LINEAR ENZYMATIC CHOLESTEROL SYSTEM
K800199 · CHH
Simmler, Inc.
Chemistry · 22d
Cleared Feb 21, 1980
LINEAR ENZYMATIC GLUCOSE SYSTEM
K800200 · CGA
Simmler, Inc.
Chemistry · 22d