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
5881–5904 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared May 11, 1993
SYNERMED CREATINE KINASE REAGENT KIT
K930932 · CGS
Synermed, Inc.
Chemistry · 77d
Cleared May 11, 1993
HEMOCARD CONTROL HB-AA, AE, FAA, FAE
K931234 · JCM
Isolab, Inc.
Chemistry · 62d
Cleared May 11, 1993
IL TEST PHOSPHORUS
K931361 · CEO
Instrumentation Laboratory CO
Chemistry · 55d
Cleared May 11, 1993
VACUTAINER BRAND LUER ADAPTER
K931367 · JKA
Bd Becton Dickinson Vacutainer...
Chemistry · 55d
Cleared May 11, 1993
IMMULITE CORTISOL
K931409 · CGR
Diagnostic Products Corp.
Chemistry · 53d
Cleared Apr 22, 1993
OLYMPUS REPLY CLINICAL CHEMISTRY ANALYZER
K925935 · JJQ
Olympus Corp.
Chemistry · 154d
Cleared Apr 22, 1993
LD-1 CONTROL-LEVEL 1 & 2
K930874 · JJX
Cala Diagnostics
Chemistry · 62d
Cleared Apr 21, 1993
IRON TEST #'S 42376/93,42324/R1A,42324/R1B,42324/R
K930166 · JIY
Em Diagnostic Systems, Inc.
Chemistry · 98d
Cleared Apr 21, 1993
RADIAS AUTOMATED IMMUNOASSAY SYSTEM
K930898 · JJI
Bio-Rad
Chemistry · 58d
Cleared Apr 20, 1993
HI CHEM BUN REAGENT KIT,PRODUCT NUMBER 88806
K925550 · CDS
Hichem Diagnostics
Chemistry · 168d
Cleared Apr 20, 1993
HI CHEM GLUCOSE REAGENT KIT, PRODUCT NO. 88807
K925551 · CGA
Hichem Diagnostics
Chemistry · 168d
Cleared Apr 20, 1993
HI CHEM ELECTROLYTE BUFFER
K925612 · JGS
Hichem Diagnostics
Chemistry · 166d
Cleared Apr 20, 1993
BECTON DICKINSON SIMULTRAC COMPONENT SYSTEM
K925842 · CEC
Bd Becton Dickinson Vacutainer...
Chemistry · 153d
Cleared Apr 20, 1993
CARDIO REP CK ISOENZYME KIT - 3310
K931050 · JHW
Helena Laboratories
Chemistry · 50d
Cleared Apr 13, 1993
CKMB ISOENZYME CONTROL-LEVEL 1,2.3
K930873 · JJT
Cala Diagnostics
Chemistry · 53d
Cleared Apr 13, 1993
CKMB CONTROL - LEVEL 1,2,3
K930875 · JJT
Cala Diagnostics
Chemistry · 53d
Cleared Apr 12, 1993
CARDIO REP-CAT. NO. 1400 & CK ISOFORMS KIT 3305
K930359 · JHT
Helena Laboratories
Chemistry · 76d
Cleared Apr 06, 1993
BESURE PLUS/(MIDSTREAM) ONE STEP PREG HOME TEST
K930488 · LCX
Syntron Bioresearch, Inc.
Chemistry · 67d
Cleared Mar 29, 1993
TRACE MICROPROTEIN REAGENT
K925794 · JGQ
Trace America, Inc.
Chemistry · 133d
Cleared Mar 29, 1993
VISTA PROLACTIN ASSAY
K926386 · CFT
Syva Co.
Chemistry · 97d
Cleared Mar 29, 1993
SAS(TM) MONOCLONAL HCG-SLIDE
K930609 · JHJ
Sa Scientific, Inc.
Chemistry · 52d
Cleared Mar 29, 1993
CREATINE KINASE (CK) REAGENT SET
K930660 · CGS
Pointe Scientific, Inc.,
Chemistry · 48d
Cleared Mar 26, 1993
ELECTROPHORESIS CONTROL LEVEL 1
K925326 · JJY
Seradyn, Inc.
Chemistry · 156d
Cleared Mar 25, 1993
PROCLINIC ONE-STEP DIPSTICK PREGNANCY TEST
K930014 · JHI
Vanguard Biomedical Corp.
Chemistry · 80d