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
12577–12600 of 13,249
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
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
Cleared Jun 28, 1978
THERMO SET ELECTRONIC TEM. CONTROLLER
K780888 · JRI
Gilford Instrument Laboratories, Inc.
Chemistry · 33d
Cleared Jun 28, 1978
AUTOMATED ELECTROPHORESIS SYSTEM
K780901 · JQT
Olympus Corp.
Chemistry · 27d
Cleared Jun 28, 1978
FISHER SPECTROPHOTOMETER
K780902 · JJQ
Bausch & Lomb, Inc.
Chemistry · 28d
Cleared Jun 28, 1978
CLINICAL ANALYZER SYSTEM
K780903 · JJQ
Bausch & Lomb, Inc.
Chemistry · 28d
Cleared Jun 28, 1978
ADJUSTABLE DISPENSOR
K780912 · JQW
Oxford Laboratories, Inc.
Chemistry · 23d
Cleared Jun 22, 1978
URIC ACID REFERENCE SERA
K780447 · JIT
Macomb Chemical Co.
Chemistry · 94d