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
12985–13008 of 13,249
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jul 11, 1977
SPECTROPHOTOMETERS,34,35,36,3600
K770825
Beckman Instruments, Inc.
Chemistry · 67d
Cleared Jul 11, 1977
STATZYME URIC ACID REAGENT
K770831 · CDO
Worthington Biochemical Corp.
Chemistry · 66d
Cleared Jul 11, 1977
STATZYME GLUCOSE
K771001 · CGA
Worthington Biochemical Corp.
Chemistry · 38d
Cleared Jul 11, 1977
UNIPAK HEMOGLOBIN
K771090 · GKK
Harleco
Chemistry · 25d
Cleared Jul 06, 1977
LABORATORY EXPENDABLE PRODUCTS
K770594 · JRC
Abco Dealers, Inc.
Chemistry · 100d
Cleared Jul 05, 1977
REAGENT KIT, ENZYMATIC AMYLASE
K770750 · JFJ
Beckman Instruments, Inc.
Chemistry · 71d
Cleared Jul 05, 1977
IN VITRO DIAG. FOR URIC ACID
K770767 · CDO
Smithkline Diagnostics, Inc.
Chemistry · 68d
Cleared Jul 05, 1977
HEMOTOLOGY PRODU&TS (5 IN ALL)
K770803 · GKK
Hycel, Inc.
Chemistry · 64d
Cleared Jul 01, 1977
CPK ULTRAZYME PLUS
K770694 · CGS
Harleco Diagnostics
Chemistry · 77d
Cleared Jun 29, 1977
BLOOD COLLECTION TUBE, GRAY
K771053 · GIM
Sherwood Medical Industries
Chemistry · 16d
Cleared Jun 29, 1977
BLOOD COLLECTION TUBE, BLUE
K771054 · GIM
Sherwood Medical Industries
Chemistry · 16d
Cleared Jun 29, 1977
BLOOD COLLECTION TUBE, RED
K771055 · GIM
Sherwood Medical Industries
Chemistry · 16d
Cleared Jun 29, 1977
BLOOD COLLECTION TUBE, GREEN
K771056 · GIM
Sherwood Medical Industries
Chemistry · 16d
Cleared Jun 27, 1977
AQUEOUS PH/BLOOD GAS CONTROLS
K770228 · JJS
Instrumentation Laboratory CO
Chemistry · 140d
Cleared Jun 27, 1977
REAGENT SYSTEM
K770504 · JGZ
American Monitor Corp.
Chemistry · 103d
Cleared Jun 27, 1977
CALCULATOR, ENZYME, TURNER
K770671 · JQP
Turner Assoc.
Chemistry · 80d
Cleared Jun 27, 1977
BLOOD COLLECTION TUBE, LAVENDER
K771052 · GIM
Sherwood Medical Industries
Chemistry · 14d
Cleared Jun 24, 1977
CREATININE TEST, SUPER SEVENTEEN
K770643 · CGX
Hycel, Inc.
Chemistry · 81d
Cleared Jun 24, 1977
UN, UV DELTA TEST ASSAY
K770654 · CDQ
Bd Becton Dickinson Vacutainer...
Chemistry · 79d
Cleared Jun 24, 1977
ANALYZER, CENTRIFUGAL, IL MULTISTAT III
K770660
Instrumentation Laboratory CO
Chemistry · 78d
Cleared Jun 17, 1977
DETER. OF PHOSPHOHEXOSE ISOMERASE
K770577 · KLJ
Sigma Chemical Co.
Chemistry · 81d
Cleared Jun 17, 1977
LDH ULTRAZYME PLUS
K770613 · CFJ
Harleco Diagnostics
Chemistry · 78d
Cleared Jun 17, 1977
REAGENT, CHLORIDE, COULTER
K770752 · CHJ
Coulter Electronics, Inc.
Chemistry · 53d
Cleared Jun 17, 1977
LIQUI SOL T4 RIA TEST KIT
K770918 · CDP
Damon Corp.
Chemistry · 29d