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
12289–12312 of 13,249
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
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
Cleared Jun 28, 1979
COULTER ACCU-ZYME IIY-GT REAGENT KIT
K790812 · JPZ
Coulter Electronics, Inc.
Chemistry · 63d
Cleared Jun 28, 1979
MULTECON BLOOD GAS CONTROL
K790813 · JJS
Ortho Diagnostics, Inc.
Chemistry · 62d
Cleared Jun 28, 1979
UV URIC ACID DETERMINATION
K790834 · CDO
The Dow Chemical Co.
Chemistry · 59d
Cleared Jun 28, 1979
THYROID CONTROL SERA CODE QAS.101
K790840 · JJY
Amersham Corp.
Chemistry · 57d
Cleared Jun 28, 1979
BIOVATION DIGITAL URINOMETER
K790862 · JRE
Biovation, Inc.
Chemistry · 52d
Cleared Jun 28, 1979
LANCER HDL SEPARATION KIT
K790865 · LBR
Sherwood Medical Co.
Chemistry · 52d