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
12313–12336 of 13,249
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
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
Cleared Jun 15, 1979
GLUCOSE (HK) REAGENT
K790786 · CFR
Gilford Diagnostics
Chemistry · 53d
Cleared Jun 15, 1979
ELECTROPHORESIS REAGENT SET, HDL
K790791 · LBT
Gelman Sciences, Inc.
Chemistry · 52d
Cleared Jun 05, 1979
FETAL MATURITY TEST PROCEDURE
K790798 · JHG
Helena Laboratories
Chemistry · 49d
Cleared May 25, 1979
RIA KIT, PROSTATIC ACID
K790580 · JFH
Monitor Science Corp.
Chemistry · 59d
Cleared May 25, 1979
EMIT CFA THYROXINE ASSAY
K790686 · KLI
Syva Co.
Chemistry · 44d
Cleared May 23, 1979
CONCEP-7-B-HCG
K790397 · JHI
Leeco Diagnostics, Inc.
Chemistry · 86d