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.

176,325 clearances · 1976 to present · Updated monthly from FDA records

Filters: Chemistry ×
13,249 results
11713–11736 of 13,249
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Dec 11, 1980
VISTA 54 LIQUID CHROMATOGRAPHY ANAL. SYS
K802725 · KZR
Varian Assoc., Inc.
Chemistry · 41d
Cleared Dec 11, 1980
125I-TESTOSTERONE TEST SET
K802728 · CDZ
Wien Laboratories, Inc.
Chemistry · 38d
Cleared Dec 11, 1980
SERA-PAK TOTAL PROTEIN REAGENT
K802742 · GGK
Miles Laboratories, Inc.
Chemistry · 38d
Cleared Dec 11, 1980
CAMPYLOBACTER SELECTIVE SUPPLEMENT (BL.)
K802753 · JSK
Oxoid U.S.A., Inc.
Chemistry · 38d
Cleared Dec 11, 1980
CHOLESTEROL STANDARDS
K802823 · JIT
Mallinckrodt Critical Care
Chemistry · 31d
Cleared Dec 11, 1980
COMBUNED CALCIUM AND PHOSPHORUS STD.
K802824 · JIX
Mallinckrodt Critical Care
Chemistry · 31d
Cleared Dec 11, 1980
COMBINED GLUCOSE AND BUN STANDARDS
K802825 · JIX
Mallinckrodt Critical Care
Chemistry · 31d
Cleared Dec 11, 1980
COMPU-CHEM II CHEMISTRY ANALYZER
K802835 · JJE
Diagnostic Aids, Inc.
Chemistry · 29d
Cleared Dec 11, 1980
BECKMAN ICS DRUG CONTROL SERA
K802854 · DIF
Beckman Instruments, Inc.
Chemistry · 28d
Cleared Dec 10, 1980
LIQUISOL TESTOSTERONE RADIOIMM. TEST KIT
K802661 · CDZ
Damon Corp.
Chemistry · 43d
Cleared Dec 10, 1980
LANCER URIC ACID AUTO/STAT KIT
K802692 · KNK
Sherwood Medical Co.
Chemistry · 41d
Cleared Dec 10, 1980
OREIA-Q-TY, ENZYME IMMUNOASSAY
K802693 · KLI
Organon, Inc.
Chemistry · 41d
Cleared Dec 10, 1980
CENTRIFICHEM COMB. SERUM-BASED CALIB.
K802741 · JIX
Union Carbide Corp.
Chemistry · 37d
Cleared Dec 10, 1980
AMES SERA-PAK CHOLESTEROL REAGENT KIT
K802743 · CHH
Miles Laboratories, Inc.
Chemistry · 37d
Cleared Dec 10, 1980
HEXOKINASE, GLUCOSE
K802810 · CFR
Beckman Instruments, Inc.
Chemistry · 33d
Cleared Dec 05, 1980
BIOLUMIN. SCREENING FOR BACT. BY ATP A.
K803077
Technology, Inc.
Chemistry
Cleared Nov 26, 1980
SPECIAL PROCEDURE AQAROSE FILM
K802395 · JJN
Electrophoresis Corp.
Chemistry · 55d
Cleared Nov 26, 1980
GENERAL PROCEDURE AGAROSE FILM
K802396 · JJN
Electrophoresis Corp. of America
Chemistry · 55d
Cleared Nov 26, 1980
CHEMISTRY ANALYZER IMPACT 400
K802609 · JJE
Gilford Instrument Laboratories, Inc.
Chemistry · 36d
Cleared Nov 26, 1980
CAFFEINE REAGENT DIAZO COLORIMETRY
K802630 · CIG
American Monitor Corp.
Chemistry · 34d
Cleared Nov 24, 1980
SERUM T4 BY ENZYME IMMUNOASSAY
K802573 · CDX
Worthington Diagnostic Systems
Chemistry · 38d
Cleared Nov 24, 1980
ANSWER AT-HOME PREGNANCY TEST KIT
K802660 · JHJ
Armkel, LLC
Chemistry · 31d
Cleared Nov 21, 1980
VITAMIN B12 FOLATE RADIOASSAY
K802037 · CCN
Corning Medical & Scientific
Chemistry · 91d
Cleared Nov 12, 1980
CBC PAP TEST KIT
K802153 · JFH
Calbiochem-Behring Corp.
Chemistry · 65d