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
12289–12312 of 13,231
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
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
Cleared Jun 28, 1979
HPL RIA KIT
K790919 · JMF
Technia Diagnostics , Ltd.
Chemistry · 45d
Cleared Jun 28, 1979
AUTO ENZYMATIC CHOLESTEROL
K790947 · CHH
Macomb Chemical Co.
Chemistry · 41d
Cleared Jun 28, 1979
LIQUID SCINTILLATION COUNTER
K790961 · JJJ
Nuclear Ent. , Ltd.
Chemistry · 37d
Cleared Jun 28, 1979
REAGENT STRIPS FOR URINALYSIS
K790965 · CDM
Miles Laboratories, Inc.
Chemistry · 37d
Cleared Jun 27, 1979
AUTOPAK CORTISOL TEST DELIVERY SYSTEM
K790906 · CGR
Micromedic Systems
Chemistry · 47d
Cleared Jun 27, 1979
AUTOPAK TEST DELIVERY SYSTEM
K790907 · CDX
Micromedic Systems
Chemistry · 47d
Cleared Jun 27, 1979
RIA, TEST SET CENTRIA T3
K790908 · CDP
Ventrex Laboratories, Inc.
Chemistry · 44d
Cleared Jun 27, 1979
RIA OF PROGESTERONE
K790911 · JLS
Calbiochem-Behring Corp.
Chemistry · 44d
Cleared Jun 22, 1979
CK-NUC REAGENT
K790916 · JHS
Smithkline Diagnostics, Inc.
Chemistry · 39d
Cleared Jun 22, 1979
SPIN CHEM CK-NAC REAGENT
K790917 · JHS
Smithkline Diagnostics, Inc.
Chemistry · 39d
Cleared Jun 22, 1979
ESKLAB REAGENT TABLETS
K790918 · JHS
Smithkline Diagnostics, Inc.
Chemistry · 39d
Cleared Jun 15, 1979
CHOLESTEROL KIT, HDL-DS
K790553 · LBS
Beckman Instruments, Inc.
Chemistry · 88d
Cleared Jun 15, 1979
BL BILIRUBINOMETER
K790608 · CIG
Advanced Instruments, Inc.
Chemistry · 78d
Cleared Jun 15, 1979
OSMOMETER MODEL 3W11
K790611 · JJM
Advanced Instruments, Inc.
Chemistry · 78d
Cleared Jun 15, 1979
NOVA 3 CHLORIDE/TOTAL DIOXIDE ANALYZER
K790653 · CGZ
Nova Corp.
Chemistry · 71d
Cleared Jun 15, 1979
PREGNOSTICON PREGNANCY TEST KIT
K790734 · JHJ
Organon, Inc.
Chemistry · 60d
Cleared Jun 15, 1979
CHEMTAB
K790772 · JIM
Boehringer Mannheim Corp.
Chemistry · 56d
Cleared Jun 15, 1979
ENZYMATIC TRIGLYCERIDES-S.V.R.
K790773 · CDT
Calbiochem-Behring Corp.
Chemistry · 56d