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
5761–5784 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Sep 28, 1993
MICROTAINER BRAND TUBE WITH EDTA
K931368 · JKA
Bd Becton Dickinson Vacutainer...
Chemistry · 195d
Cleared Sep 28, 1993
MEDIX BIOTECH BESTEST HCG-URINE TEST KIT
K932758 · JHI
Medix Biotech, Inc.
Chemistry · 117d
Cleared Sep 27, 1993
UREA KIT
K923506 · CDQ
Randox Laboratories, Ltd.
Chemistry · 439d
Cleared Sep 27, 1993
SYNELISA CORTISOL
K931177 · CGR
Elias U.S.A., Inc.
Chemistry · 202d
Cleared Sep 27, 1993
CALCIUM TEST ITEM NUMBER 65409
K932158 · CIC
Em Diagnostic Systems, Inc.
Chemistry · 146d
Cleared Sep 27, 1993
URIC ACID TEST ITEM NUMBER 65422
K932162 · CDO
Em Diagnostic Systems, Inc.
Chemistry · 146d
Cleared Sep 24, 1993
ENZYMATIC CO2 REAGENT, MODIFICATION
K932267 · KHS
Intersect Systems, Inc.
Chemistry · 163d
Cleared Sep 24, 1993
DADE URINE CHEMISTRY CONTROL, LEVEL 1 & LEVEL 2
K933435 · JJY
Baxter Diagnostics, Inc.
Chemistry · 72d
Cleared Sep 24, 1993
SAS(TM) HCG URINE CONTROLS, VARIOUS SIZES
K933744 · JJX
Sa Scientific, Inc.
Chemistry · 57d
Cleared Sep 21, 1993
COBAS CORE FSH EIA
K930304 · CGJ
Roche Diagnostic Systems, Inc.
Chemistry · 243d
Cleared Sep 21, 1993
ACE CLINICAL CHEMISTRY SYSTEM
K931786 · JJE
Schiapparelli Biosystems, Inc.
Chemistry · 165d
Cleared Sep 21, 1993
OLYMPUS CREATININE REAGENT
K931939 · CGX
Olympus Corp.
Chemistry · 155d
Cleared Sep 21, 1993
SYSTEMATE DIRECT BILIRUBIN CAT. NO. 65406
K932159 · CIG
Em Diagnostic Systems, Inc.
Chemistry · 140d
Cleared Sep 21, 1993
AIA-PACK PA CALIBRATION VERIFICATION/LINEARITY TES
K932178 · JJX
Tosoh Medics, Inc.
Chemistry · 139d
Cleared Sep 17, 1993
OLYMPUS CHLORID REAGENT, MODIFIED
K932528 · CHJ
Olympus Corp.
Chemistry · 148d
Cleared Sep 10, 1993
HCG MIDSTREAM PREGNANCY TEST
K931997 · LCX
Mizuho USA, Inc.
Chemistry · 140d
Cleared Sep 09, 1993
AUTOBEAD TSH ENZYME IMMUNOASSAY REAGENT KIT
K930006 · JLW
Bio-Chem Laboratory Systems, Inc.
Chemistry · 248d
Cleared Sep 08, 1993
GLUCOFILM TEST STRIPS
K926360 · CGA
Heraeus Kulzer, Inc.
Chemistry · 261d
Cleared Sep 08, 1993
ACCU-CHEK ADVANTAGE BLOOD GLUCOSE SYSTEM
K930979 · CGA
Boehringer Mannheim Corp.
Chemistry · 195d
Cleared Sep 08, 1993
CHEMILUMINESCENCE FREE T3 IMMUNOASSAY
K931600 · CDP
Nichols Institute
Chemistry · 160d
Cleared Sep 08, 1993
OLYMPUS REPLY INORGANIC PHOSPHOROUS REAGENT
K931835 · CEO
Olympus Corp.
Chemistry · 148d
Cleared Sep 08, 1993
SYNERMED GGT REAGENT KIT
K931958 · JQB
Synermed, Inc.
Chemistry · 141d
Cleared Sep 08, 1993
AMP ALKALINE PHOSPHATASE REAGENT KIT
K931986 · CJE
Synermed, Inc.
Chemistry · 139d
Cleared Sep 08, 1993
UREA NITROGEN TEST ITEM NUMBER 65408
K932161 · CDQ
Em Diagnostic Systems, Inc.
Chemistry · 127d