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.

176,325 clearances · 1976 to present · Updated monthly from FDA records

Filters: Chemistry ×
13,249 results
11905–11928 of 13,249
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared May 28, 1980
REAGENTS FOR DETERM. SODIUM IN HUMAN SUM
K800676 · JGS
Diagnostic Solutions, Inc.
Chemistry · 63d
Cleared May 28, 1980
REAGENTS FOR DETERM. SERUM IRON IN HUMAN
K800677 · JIY
Diagnostic Solutions, Inc.
Chemistry · 63d
Cleared May 28, 1980
REAGENTS FOR DETERM. ALBUMIN IN HUMAN
K800678 · CIX
Diagnostic Solutions, Inc.
Chemistry · 63d
Cleared May 28, 1980
REAGENTS FOR DETERM. ALKALINE PHOSPHATAS
K800679 · CJE
Diagnostic Solutions, Inc.
Chemistry · 63d
Cleared May 28, 1980
REAGENTS FOR DETERM. CALCIUM IN HUMAN
K800680 · CIC
Diagnostic Solutions, Inc.
Chemistry · 63d
Cleared May 28, 1980
REAGENTS FOR DETERM. CHOLESTEROL/SERUM
K800682 · CGO
Diagnostic Solutions, Inc.
Chemistry · 63d
Cleared May 28, 1980
REAGENT FOR DETERM. CHLORIDE IN HUMAN/SM
K800683 · CHJ
Diagnostic Solutions, Inc.
Chemistry · 63d
Cleared May 28, 1980
REAGENT FOR DETERM. CREATINE PHOSPHOKINA
K800684 · JHY
Diagnostic Solutions, Inc.
Chemistry · 63d
Cleared May 28, 1980
REAGENT FOR DETERM. CREATININE IN H/SERU
K800685 · CGX
Diagnostic Solutions, Inc.
Chemistry · 63d
Cleared May 28, 1980
REAGENT FOR DETERM. DIRECT BILIRUBIN
K800686 · CIG
Diagnostic Solutions, Inc.
Chemistry · 63d
Cleared May 28, 1980
REAGENT FOR DETERM. GLUCOSE IN H/SERUM
K800687 · CGA
Diagnostic Solutions, Inc.
Chemistry · 63d
Cleared May 28, 1980
REAGENT FOR DETERM. GLUTAMIC-OXALOACETIC
K800688 · CIT
Diagnostic Solutions, Inc.
Chemistry · 63d
Cleared May 28, 1980
REAGENT FOR DETERM. INORGANIC/PHOSPHORUS
K800690 · CEO
Diagnostic Solutions, Inc.
Chemistry · 63d
Cleared May 28, 1980
REAGENT FOR DETERM. LACTATE/DEHYDROGENAS
K800691 · CFJ
Diagnostic Solutions, Inc.
Chemistry · 63d
Cleared May 28, 1980
REAGENT FOR DETERM. POTASSIUM/IN HUMAN
K800692 · CEM
Diagnostic Solutions, Inc.
Chemistry · 63d
Cleared May 28, 1980
IL MODEL 773 FLUORESCENCE LIGHT SCATTER
K801026 · JJG
Instrumentation Laboratory CO
Chemistry · 27d
Cleared May 28, 1980
RIAUSE AUTO PROCESSOR
K801030 · JQW
Electro-Nucleonics Laboratories, Inc.
Chemistry · 27d
Cleared May 28, 1980
CENTRIA SYSTEM 2 AUTOMATED METHOD/RIA
K801037 · LCI
Union Carbide Corp.
Chemistry · 26d
Cleared May 28, 1980
P-NITROPHENYL PHOSPHATE
K801086
Macomb Chemical Co.
Chemistry · 21d
Cleared May 28, 1980
J.T. BAKER NEPHELOMETER
K801089 · JQX
J.T. Baker Chemical Co.
Chemistry · 20d
Cleared May 23, 1980
DATA-ZYME GLUCOSE HEXOKINASE COLOZIMETRI
K801051 · CFR
Data Medical Associates, Inc.
Chemistry · 18d
Cleared May 23, 1980
DATA-ZYME GLUCOSE HEXOKINASE UV
K801052 · CFR
Data Medical Associates, Inc.
Chemistry · 18d
Cleared May 23, 1980
LANCER GLUCOSE RATE REAGENT KIT
K801071 · CGA
Sherwood Medical Industries
Chemistry · 17d
Cleared May 14, 1980
NORDICLAB ESTRADIOL RIA TEST
K800920 · CHP
Nordiclab Intl.
Chemistry · 23d