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
4321–4344 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Nov 26, 1997
CARDS Q.S. HCG SERUM/URINE
K973858 · JHI
Quidel Corp.
Chemistry · 48d
Cleared Nov 26, 1997
SERUM HCG CONTROL SET (NEGATIVE, LOW POSITIVE AND HIGH POSITIVE)
K974108 · JJX
Quidel Corp.
Chemistry · 26d
Cleared Nov 25, 1997
ABBOTT AXSYM TROPONIN-I
K974103 · MMI
Abbott Laboratories
Chemistry · 25d
Cleared Nov 24, 1997
17 B-ESTRADIOL (ELISA)
K973901 · CHP
Kmi Diagnostics, Inc.
Chemistry · 41d
Cleared Nov 24, 1997
UREA-SL ASSAY CATALOGUE NUMBER 239-10, 239-30
K973931 · CDQ
Diagnostic Chemicals , Ltd.
Chemistry · 40d
Cleared Nov 21, 1997
ROCHE UNIMATE HDL DIRECT REAGEN (WITH POL CLAIM)
K973369 · LBR
Roche Diagnostic Systems, Inc.
Chemistry · 74d
Cleared Nov 20, 1997
AUTODELFIA NEONATAL HTSH L KIT (B077-112)
K973276 · JLW
Eg &G Wallac
Chemistry · 79d
Cleared Nov 13, 1997
ELECSYS VITAMIN B12 ASSAY
K973702 · CDD
Boehringer Mannheim Corp.
Chemistry · 48d
Cleared Nov 13, 1997
DHEA-S
K973897 · JKC
Kmi Diagnostics, Inc.
Chemistry · 30d
Cleared Nov 13, 1997
PROGESTERONE ELISA
K973898 · JLS
Kmi Diagnostics, Inc.
Chemistry · 30d
Cleared Nov 13, 1997
ASPARTATE AMINOTRANSFERASE-SL ASSAY, CATALOGUE NUMBER 319-10, 319-30
K974001 · CIT
Diagnostic Chemicals , Ltd.
Chemistry · 23d
Cleared Nov 12, 1997
ELECSYS FOLATE
K973674 · CDD
Boehringer Mannheim Corp.
Chemistry · 47d
Cleared Nov 10, 1997
ACCESS TROPONIN I REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER
K974075 · MMI
Beckman Instruments, Inc.
Chemistry · 12d
Cleared Nov 06, 1997
ACE PHENOBARBITAL REAGENT/AED CALIBRATORS
K973536 · DLJ
Schiapparelli Biosystems, Inc.
Chemistry · 49d
Cleared Nov 06, 1997
DADE TRU-LIQUID CARDIAC CONTROL
K973974 · JJT
Dade Intl., Inc.
Chemistry · 17d
Cleared Nov 04, 1997
OSOM CARD HCG-URINE TEST
K973879 · JHI
Wyntek Diagnostics, Inc.
Chemistry · 55d
Cleared Nov 04, 1997
SERUM IRON-SL ASSAY, CATALOGUE NUMBERS 157-10, 157-30
K973933 · JIY
Diagnostic Chemicals , Ltd.
Chemistry · 20d
Cleared Nov 04, 1997
ELECSYS CALLCHECK DIGOXIN
K973973 · DMP
Boehringer Mannheim Corp.
Chemistry · 15d
Cleared Nov 04, 1997
Y-GLUTAMYLTRANSFERASE-SL ASSAY , CATALOGE NUMBER 324-10, 324-30
K974000 · JQB
Diagnostic Chemicals , Ltd.
Chemistry · 14d
Cleared Oct 31, 1997
DUET GLUCOSE CONTROL MONITORING SYSTEM
K973140 · CGA
Lxn Corp.
Chemistry · 71d
Cleared Oct 31, 1997
ACTIVE INTACT PTH
K973514 · CEW
Diagnostic Systems Laboratories, Inc.
Chemistry · 44d
Cleared Oct 31, 1997
QUICK CARD HCG ONE STEP PREGNANCY TEST
K973570 · LCX
Phamatech
Chemistry · 42d
Cleared Oct 31, 1997
ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER
K973743 · CHP
Beckman Instruments, Inc.
Chemistry · 30d
Cleared Oct 31, 1997
ACCESS TOTAL T3 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER
K973966 · CDP
Beckman Instruments, Inc.
Chemistry · 14d