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
6265–6288 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Mar 24, 1992
MILES ALANINE AMINOTRANSFERASE SERA-PAK METHOD
K920335 · CKA
Heraeus Kulzer, Inc.
Chemistry · 60d
Cleared Mar 24, 1992
DIRECT PREGNANCY TEST
K920716 · JHJ
Tech-Co, Inc.
Chemistry · 35d
Cleared Mar 24, 1992
CHEMSTRIP URINE ANALYZER
K921087 · KQO
Boehringer Mannheim Corp.
Chemistry · 18d
Cleared Mar 23, 1992
CHEM-CHEM MULTI-ANALYTE (MODIFIED)
K920350 · JJY
Streck Laboratories, Inc.
Chemistry · 59d
Cleared Mar 23, 1992
AMERLEX-M EXTENDED RANGE HUMAN CHORIONIC GONADATR
K920505 · JHI
Eastman Kodak Company
Chemistry · 47d
Cleared Mar 23, 1992
AMERLEX-M HIGH SENSITIVITY UNCONJUGATED ESTRIOL
K920576 · CGI
Eastman Kodak Company
Chemistry · 42d
Cleared Mar 23, 1992
MP/S SINGLE WAVELENGTH MINI PHOTOMETER
K920914 · JJQ
Artel, Inc.
Chemistry · 25d
Cleared Mar 23, 1992
SYNERMED LDHH-L REAGENT KIT
K921025 · CFJ
Synermed, Inc.
Chemistry · 20d
Cleared Mar 19, 1992
ABBOTT VERTEX ANALYZER
K920559 · JJJ
Abbott Laboratories
Chemistry · 41d
Cleared Mar 19, 1992
MICROLITE MICROTITER PLATE LUMINOMETER ML2200
K920888 · KHO
Dynatech Laboratories, Inc.
Chemistry · 37d
Cleared Mar 18, 1992
RIATRAC PLUS
K914958 · JJY
Becton Dickinson Advanced Diagnostics
Chemistry · 134d
Cleared Mar 18, 1992
ENCORE
K915113 · JJQ
Heraeus Kulzer, Inc.
Chemistry · 126d
Cleared Mar 18, 1992
DMA LD KINETIC PROCEDURE
K915803 · CFJ
Data Medical Associates, Inc.
Chemistry · 85d
Cleared Mar 18, 1992
PROLACTIN ENZYME IMMUNOASSAY TEST KIT (MODIFIED)
K920345 · CFT
Medix Biotech, Inc.
Chemistry · 51d
Cleared Mar 18, 1992
IMMUCHEM TSH-MW ELISA
K920442 · JLW
Icn Biomedicals, Inc.
Chemistry · 44d
Cleared Mar 17, 1992
CLINICAL CHEM.ANAL.ACID,PROSTATIC ACID PHOSPHATASE
K914167 · CKE
Eastman Kodak Company
Chemistry · 182d
Cleared Mar 17, 1992
TRI-POINT LIQUIMMUNE LIGAND CONTROL LEVELS 1,2,3
K914204 · JJY
Medical Analysis Systems, Inc.
Chemistry · 180d
Cleared Mar 17, 1992
MODEL 560 EXPRESS CLINICAL CHEMISTRY ANALYZER
K915366 · JJE
Ciba Corning Diagnostics Corp.
Chemistry · 111d
Cleared Mar 17, 1992
DSL ACTIVE SHBG (DSL 7400)
K915823 · CDZ
Diagnostic Systems Laboratories, Inc.
Chemistry · 78d
Cleared Mar 11, 1992
IL TEST(TM) UREA NITROGEN
K914877 · CDQ
Instrumentation Laboratory CO
Chemistry · 134d
Cleared Mar 11, 1992
AMERLITE PROCESSING CENTER
K915680 · JJQ
Eastman Kodak Company
Chemistry · 83d
Cleared Mar 11, 1992
STC DIAGNOSTICS BENZOYLECGONINE EIA
K915785 · JXO
Solarcare Technologies Corp,Inc.
Chemistry · 78d
Cleared Mar 11, 1992
LH GEN III SELF-TEST/CONCEIVE
K920160 · CEP
Quidel Corp.
Chemistry · 57d
Cleared Mar 11, 1992
SYN ELISA MICRO ALBUMIN
K920216 · JIR
Elias U.S.A., Inc.
Chemistry · 55d