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
12553–12576 of 13,231
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Aug 14, 1978
CLINIRIA TOTAL T-4 (RIA) TEST
K781181 · CDX
Miles Laboratories, Inc.
Chemistry · 31d
Cleared Aug 14, 1978
MICRO THYROXINE REAGENT SYSTEM
K781182 · CDX
Bd Becton Dickinson Vacutainer...
Chemistry · 31d
Cleared Aug 14, 1978
UNISTAT BILIRUBINOMETER
K781241 · JJQ
American Optical Corp.
Chemistry · 26d
Cleared Aug 11, 1978
CONJUGATED BILE ACIDS RIA KIT
K781337 · KWW
Bd Becton Dickinson Vacutainer...
Chemistry · 8d
Cleared Aug 10, 1978
TRAP-BLOOD VESSEL STABILIZATION DEVICE
K781072 · JIT
Ayer, Patrick, M.D.
Chemistry · 45d
Cleared Aug 10, 1978
ECA BUFFER, PH 816
K781116 · CEF
Electrophoresis Corp. of America
Chemistry · 38d
Cleared Aug 10, 1978
ECA PREP
K781117 · CEF
Electrophoresis Corp. of America
Chemistry · 38d
Cleared Aug 10, 1978
ECA BUFFER PH 8.8
K781118 · CEF
Electrophoresis Corp. of America
Chemistry · 38d
Cleared Aug 10, 1978
TRICHLORACETIC ACID 7.5%
K781120 · CEF
Electrophoresis Corp. of America
Chemistry · 38d
Cleared Aug 10, 1978
PONCEAU S
K781123 · CEF
Electrophoresis Corp. of America
Chemistry · 38d
Cleared Aug 10, 1978
CPK ISOENZYME REAGENT
K781124 · JHW
Electrophoresis Corp. of America
Chemistry · 38d
Cleared Aug 10, 1978
LDH ISOENZYME REAGENT
K781125 · CFE
Electrophoresis Corp. of America
Chemistry · 38d
Cleared Aug 10, 1978
LDH (UV KINETIC)
K781128 · CFJ
Macomb Chemical Co.
Chemistry · 41d
Cleared Aug 10, 1978
CHEMLAR
K781132 · JFS
Hi Chem, Inc.
Chemistry · 38d
Cleared Aug 08, 1978
UNIT, SPECTRA, CORRECTED, DIFFERENTIAL
K780680
The Perkin-Elmer Corp.
Chemistry · 106d
Cleared Jul 28, 1978
ENZYMATIC REAGENT FOR CHOLESTEROL MEAS
K781013 · CHH
Coulter Electronics, Inc.
Chemistry · 42d
Cleared Jul 27, 1978
QUANTITATIVE DETERMINATION OF PORPHYRINS
K780455 · JKJ
Whale Scientific, Inc.
Chemistry · 129d
Cleared Jul 27, 1978
PRINCETON BIOMEDIX URICASE (UV)
K780859 · CDO
Bd Becton Dickinson Vacutainer...
Chemistry · 64d
Cleared Jul 27, 1978
CALCIUM REAGENT SYSTEM NO. 585
K780983 · CIC
Sigma Chemical Co.
Chemistry · 43d
Cleared Jul 27, 1978
HMA URIC ACID TEST
K781004 · KNK
Hycel, Inc.
Chemistry · 41d
Cleared Jul 27, 1978
ANALYZER, SERUM IRON & TOTAL IRON BINDIN
K781009 · JMD
Environmental Sciences Assoc., Inc.
Chemistry · 38d
Cleared Jul 27, 1978
(AST) OR (ALT) UV DETERM. PHY. PHOS.
K781020 · CIT
The Dow Chemical Co.
Chemistry · 42d
Cleared Jul 27, 1978
CHOLESTEROL & HDL CHOL. PROCEDURE
K781165
Data Medical Associates, Inc.
Chemistry · 15d
Cleared Jun 28, 1978
DILUTER/DISPENSER
K780882 · JQW
Innovative Medical Systems, Inc.
Chemistry · 29d