FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Chemistry ×
13,231 results
12265–12288 of 13,231
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jul 30, 1979
HCG RIA PREGNANCY TEST
K791206 · JHI
Hoffmann-La Roche, Inc.
Chemistry · 31d
Cleared Jul 30, 1979
UCG-LYPHOTEST
K791309 · JHJ
Wampole Laboratories
Chemistry · 14d
Cleared Jul 30, 1979
FLUOROMATIC ANALYZER AND AUTOSAMPLER
K791329 · KHO
Bio-Rad
Chemistry · 12d
Cleared Jul 24, 1979
RIA, INSULIN, DOUBLE ANTIBODY
K790630 · CFP
Endocrine-Metabolic Center
Chemistry · 119d
Cleared Jul 24, 1979
PROGESTERONE RADIOIMMUNOASSAY KIT
K791051 · JLS
Cis Radiopharmaceuticals, Inc.
Chemistry · 48d
Cleared Jul 24, 1979
BECKMAN ELECTROPHORESIS OVEN/INCUBATOR
K791077 · JRJ
Beckman Instruments, Inc.
Chemistry · 42d
Cleared Jul 24, 1979
PLUS CHEM S.C.E. REAGENT
K791080 · CIT
Smithkline Diagnostics, Inc.
Chemistry · 42d
Cleared Jul 17, 1979
LIPASE REAGENT SET
K790796 · CET
Alta Diagnostics, Inc.
Chemistry · 84d
Cleared Jul 17, 1979
AMYLASE REAGENT SET
K790797 · KHM
Alta Diagnostics, Inc.
Chemistry · 84d
Cleared Jul 17, 1979
HUMAN CHORIONIC GONADOTROPHIN STANDARDS
K790863 · JHI
Pcl-Ria, Inc.
Chemistry · 71d
Cleared Jul 17, 1979
RABBIT ANTISERUM TO HUMAN CHORIONIC
K790864 · JHI
Pcl-Ria, Inc.
Chemistry · 71d
Cleared Jul 17, 1979
LABELED HUMAN CHORIONIC GONADOTROPHIN
K790876 · JHI
Pcl-Ria, Inc.
Chemistry · 71d
Cleared Jul 17, 1979
P.A.P. RIA CONTROL SERUM PACK
K790985 · JJT
Mallinckrodt Critical Care
Chemistry · 53d
Cleared Jul 17, 1979
FERMCOTEST R BUN RATE REAGENT TEST KIT
K791018 · CDS
Fermco Biochemics, Inc.
Chemistry · 46d
Cleared Jul 17, 1979
NORMAL PROTEIN ELECTROPHORESIS CONTROL
K791029 · JJX
Beckman Instruments, Inc.
Chemistry · 43d
Cleared Jul 17, 1979
ABNORMAL PROTEIN ELECTROPHORESIS CONTROL
K791031 · JJX
Beckman Instruments, Inc.
Chemistry · 43d
Cleared Jul 17, 1979
GAMMADAB (125 1) FOLATE RADIOASSAY KIT
K791079 · CGN
Clinical Assays, Inc.
Chemistry · 35d
Cleared Jul 17, 1979
SPIN CHEM REAGENT, DETERMINATION OF LDH-
K791081 · CFJ
Smithkline Diagnostics, Inc.
Chemistry · 35d
Cleared Jul 17, 1979
SPIN CHEM REAGENT, DETERMINATION OF AST
K791082 · CIT
Smithkline Diagnostics, Inc.
Chemistry · 35d
Cleared Jul 17, 1979
SPIN CHEM, DETERMINATION OF ALT (GPT)
K791083 · CKA
Smithkline Diagnostics, Inc.
Chemistry · 35d
Cleared Jul 17, 1979
PLUS CHEM, DETERMINATION OF ALT (GPT)
K791084 · CKA
Smithkline Diagnostics, Inc.
Chemistry · 35d
Cleared Jul 17, 1979
PLUS CHEM, DETERMINATION OF LD (LDH-P)
K791085 · CFJ
Smithkline Diagnostics, Inc.
Chemistry · 35d
Cleared Jul 17, 1979
CARY 210 SERIES, SPECTROPHOTOMETER
K791102 · JJQ
Varian Assoc., Inc.
Chemistry · 34d
Cleared Jun 28, 1979
SYRINGE TONOMETER
K790803
Medicor USA , Ltd.
Chemistry · 64d