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
8113–8136 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Nov 23, 1987
MODIFIED PARAMAX GLUCOSE REAGENT
K873936 · CFR
Baxter Healthcare Corp
Chemistry · 59d
Cleared Nov 23, 1987
A-GENT LIQUID AMYLASE
K873944 · JFJ
Abbott Laboratories
Chemistry · 56d
Cleared Nov 23, 1987
CIBA CORNING MAGIC LITE T3 IMMUNOASSAY
K873945 · CDP
Ciba Corning Diagnostics Corp.
Chemistry · 56d
Cleared Nov 23, 1987
TITAN GEL REP LDH-12 HV
K874143 · CFE
Helena Laboratories
Chemistry · 41d
Cleared Nov 23, 1987
TITAN GEL REP CPK-6 HV
K874144 · JHX
Helena Laboratories
Chemistry · 41d
Cleared Nov 23, 1987
ALBUMIN (BCG) FOR CONTINUOUS FLOW INSTRUMENTS
K874163 · CIX
Catachem, Inc.
Chemistry · 41d
Cleared Nov 23, 1987
PRECINORM L
K874230 · JJY
Boehringer Mannheim Corp.
Chemistry · 39d
Cleared Nov 23, 1987
VENTRESCREEN, HCG URINE
K874258 · JHI
Ventrex Laboratories, Inc.
Chemistry · 34d
Cleared Nov 23, 1987
WAKO(TM) FE C
K874263 · JIY
Wako Chemicals USA, Inc.
Chemistry · 34d
Cleared Nov 23, 1987
N-TACT PTH BY IMMUNORADIOMETRIC ASSAY (IRMA)
K874299 · CEW
Incstar Corp.
Chemistry · 34d
Cleared Nov 23, 1987
BICARBONATE
K874435 · KHS
Boehringer Mannheim Corp.
Chemistry · 26d
Cleared Nov 23, 1987
EASY-TEST UREA NITROGEN (BUN) ITEM NUMBER: 19010
K874477 · CDQ
Em Diagnostic Systems, Inc.
Chemistry · 21d
Cleared Nov 06, 1987
EASY-TEST CREATININE (CREA) ITEM NO. 19009
K874088 · CGX
Em Diagnostic Systems, Inc.
Chemistry · 30d
Cleared Nov 05, 1987
WAKO(TM) AUTOKIT CK-NAC
K873201 · CGS
Wako Chemicals USA, Inc.
Chemistry · 84d
Cleared Nov 05, 1987
AMERLITE TT4 ASSAY (240/480/144 TEST KITS)
K873976 · KLI
Amersham Corp.
Chemistry · 37d
Cleared Nov 05, 1987
TITAN GEL REP CPK-12 HV
K874146 · CGS
Helena Laboratories
Chemistry · 23d
Cleared Nov 04, 1987
PROJECT 300 MICROASSAY BP-12, EIA MINILAB
K873451 · JJQ
Awareness Technology, Inc.
Chemistry · 69d
Cleared Nov 04, 1987
1205 BETAPLATE LIQUID SCINTILLATION COUNTER
K874094 · JJJ
Lkb Instruments, Inc.
Chemistry · 35d
Cleared Nov 04, 1987
TITAN GEL REP CPK/LDH ISOENZYME CONTROL
K874141 · JJT
Helena Laboratories
Chemistry · 22d
Cleared Nov 04, 1987
EASY-TEST PHOSPHORUS (PHOS) ITEM NO. 16687
K874153 · CEO
Em Diagnostic Systems, Inc.
Chemistry · 22d
Cleared Nov 04, 1987
DART (R) ELECTROLYTE REAGENT SYSTEM
K874185 · JGS
Coulter Electronics, Inc.
Chemistry · 21d
Cleared Nov 04, 1987
SYNTRON BIORESEARCH U-TEST PREGNANCY TEST
K874248 · LCX
Syntron Bioresearch, Inc.
Chemistry · 19d
Cleared Nov 03, 1987
AMERLITE TT3 ASSAY, LAN.0003/1003/2003
K873858 · CDP
Amersham Corp.
Chemistry · 42d
Cleared Nov 03, 1987
TSH ENZYME IMMUNOASSAY TEST KIT NO. MB-1093
K874061 · JLW
Medix Biotech, Inc.
Chemistry · 29d