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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Chemistry ×
13,237 results
8185–8208 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Oct 02, 1987
WAKO(TM) AUTOKIT ALP
K873333 · CJE
Wako Chemicals USA, Inc.
Chemistry · 44d
Cleared Oct 02, 1987
WAKO(TM) AUTOKIT CALCIUM
K873334 · CIC
Wako Chemicals USA, Inc.
Chemistry · 44d
Cleared Oct 02, 1987
WAKO(TM) AUTOKIT UREA N
K873335 · CDQ
Wako Chemicals USA, Inc.
Chemistry · 44d
Cleared Oct 02, 1987
CREATININE REAGENT
K873365 · CGX
Sigma Diagnostics, Inc.
Chemistry · 42d
Cleared Oct 02, 1987
TITAN GEL HDL CHOLESTEROL KIT
K873547 · LBT
Helena Laboratories
Chemistry · 31d
Cleared Oct 02, 1987
CONJUGATED BILIRUBIN (CBIL) ITEM NO. 67684/95
K873551 · CIG
Em Diagnostic Systems, Inc.
Chemistry · 32d
Cleared Oct 02, 1987
MULTICHEM CALCIUM S0910
K873697 · CIC
Simmler, Inc.
Chemistry · 18d
Cleared Sep 29, 1987
G-GT STANDARD CALIBRATOR
K871759 · JIT
Wako Chemicals USA, Inc.
Chemistry · 147d
Cleared Sep 29, 1987
STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY
K873171 · JHX
American Dade
Chemistry · 49d
Cleared Sep 29, 1987
LH MAIACLONE IMMUNORADIO. ASSAY KIT, MAG SOLID PHA
K873186 · CEP
Serono Diagnostics, Inc.
Chemistry · 48d
Cleared Sep 29, 1987
QUANTIMETRIX URINE DRUGS OF ABUSE CONTROL
K873467 · DIF
Quantimetrix Medical Industries
Chemistry · 32d
Cleared Sep 29, 1987
MICRO-CHEM ANALYZER
K873638 · JJQ
Ocean Scientific, Inc.
Chemistry · 20d
Cleared Sep 29, 1987
SPECTROPHOTOMETER (MICROASSAY PLATE READERS)
K873678 · JJQ
Slt Labinstruments, Inc.
Chemistry · 15d
Cleared Sep 29, 1987
ALKALINE PHOSPHATASE (ALK P) TESTPACK #67690/95
K873681 · CJE
Em Diagnostic Systems, Inc.
Chemistry · 15d
Cleared Sep 25, 1987
DOUBLE ANTIBODY ULTRA-PTH #KPTD1 AND KPTD2
K871970 · CEW
Diagnostic Products Corp.
Chemistry · 127d
Cleared Sep 25, 1987
PROLACTIN MAIACLONE IMMUNORADIO. KIT, MAG SOL PHA
K873400 · CFT
Serono Diagnostics, Inc.
Chemistry · 32d
Cleared Sep 22, 1987
WAKO(TM) PRETEST 8A
K873553 · JJB
Wako Chemicals USA, Inc.
Chemistry · 25d
Cleared Sep 22, 1987
AUTO-EIA
K873583 · JJQ
Labsystems, Inc.
Chemistry · 19d
Cleared Sep 22, 1987
FINNIGAN MAT INCOS 50
K873603 · JJO
Finnigan Corp.
Chemistry · 18d
Cleared Sep 18, 1987
CALCIUM CALIBRATOR
K872051 · JIS
Wako Chemicals USA, Inc.
Chemistry · 113d
Cleared Sep 18, 1987
PRL SEROZYME IMMUNOENZ. ASSAY KIT, MAG. SOLID PHAS
K872862 · CFT
Serono Diagnostics, Inc.
Chemistry · 59d
Cleared Sep 16, 1987
WAKO(TM) ZN TEST
K863920
Wako Chemicals USA, Inc.
Chemistry · 343d
Cleared Sep 16, 1987
GLUCOCHEK S.C. WITH AUDIO OPTION
K871586 · CGA
Larken Industries, Inc.
Chemistry · 146d
Cleared Sep 16, 1987
COULTER DART CK-MB ISOENZYME REAGENT SYSTEM
K872041 · JHT
Coulter Electronics, Inc.
Chemistry · 112d