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
11881–11904 of 13,231
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared May 30, 1980
REAGENTS FOR DETERM. CO2 IN HUMAN SERUM
K800681 · KMS
Diagnostic Solutions, Inc.
Chemistry · 65d
Cleared May 30, 1980
REAGENT FOR DETERM. GLUTAMIC-PYRUVIC-
K800689 · CKA
Diagnostic Solutions, Inc.
Chemistry · 65d
Cleared May 28, 1980
SMAC REPLACEMENT REAGENTS/DETERM-URIC-AC
K800672 · CDH
Diagnostic Solutions, Inc.
Chemistry · 63d
Cleared May 28, 1980
SMAC REPLACEMENT REAGENTS/OF BUN-SERUM
K800673 · CDW
Diagnostic Solutions, Inc.
Chemistry · 63d
Cleared May 28, 1980
SMAC REPLACEMENT/TOTAL PROTEIN HUMAN SER
K800674 · CEK
Diagnostic Solutions, Inc.
Chemistry · 63d
Cleared May 28, 1980
REAGENTS FOR DETERM. TOTAL BILIRUBIN
K800675 · CIG
Diagnostic Solutions, Inc.
Chemistry · 63d
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