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
12553–12576 of 13,249
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Aug 31, 1978
ICS NORMAL CONTROL SERUM
K781355 · DGR
Beckman Instruments, Inc.
Chemistry · 24d
Cleared Aug 31, 1978
DUAL COMPONENT STANDARDS
K781423 · JIT
Abbott Laboratories
Chemistry · 14d
Cleared Aug 21, 1978
DATA TERMINAL MODEL 722
K781217 · JQP
Corning Medical & Scientific
Chemistry · 35d
Cleared Aug 21, 1978
BUN (UREASE) REAGENT
K781253 · CDN
Coulter Electronics, Inc.
Chemistry · 31d
Cleared Aug 17, 1978
ENZYMATIC TRIGLYCERIDES REAGENT KIT
K781240 · CDT
J.T. Baker Chemical Co.
Chemistry · 28d
Cleared Aug 14, 1978
QUICKRATE REACTION RATE ANALYZER
K780972 · JJI
Olympus Corp.
Chemistry · 63d
Cleared Aug 14, 1978
DROPPERS, SOLUTION, IODINE
K781061 · JTS
Marion Laboratories, Inc.
Chemistry · 49d
Cleared Aug 14, 1978
DROPPER, SOLUTION TRICHROME, CEPTI-SEAL
K781062 · HYW
Marion Laboratories, Inc.
Chemistry · 49d
Cleared Aug 14, 1978
T3 STANDARDS IN HUMAN SERUM
K781069 · JIT
Pcl-Ria, Inc.
Chemistry · 49d
Cleared Aug 14, 1978
STANDARDS, HORMONE, THYROID STIMULATING
K781071 · JIT
Pcl-Ria, Inc.
Chemistry · 49d
Cleared Aug 14, 1978
STATTEK-GLUCOSE LOW LEVEL
K781075 · CGA
Boehringer Mannheim Corp.
Chemistry · 47d
Cleared Aug 14, 1978
CHEMISTRY ANALYZER
K781076 · JJE
Johns Scientific, Inc.
Chemistry · 47d
Cleared Aug 14, 1978
HDL CENTRIFIKIT
K781093 · LBR
Beckman Instruments, Inc.
Chemistry · 45d
Cleared Aug 14, 1978
DELTA TEST AMYLASE/LIPASE CONTS. I,II
K781100 · JJT
Bd Becton Dickinson Vacutainer...
Chemistry · 42d
Cleared Aug 14, 1978
ECA HEME BUFFER
K781119 · JBD
Electrophoresis Corp. of America
Chemistry · 42d
Cleared Aug 14, 1978
SPECTROPHOTOMETER
K781138 · JJQ
Bausch & Lomb, Inc.
Chemistry · 39d
Cleared Aug 14, 1978
CPK-L TUBE
K781149 · CGS
Bd Becton Dickinson Vacutainer...
Chemistry · 34d
Cleared Aug 14, 1978
CLINIRIA T-3 UPTAKE TEST
K781180 · KHQ
Miles Laboratories, Inc.
Chemistry · 31d
Cleared Aug 14, 1978
CLINIRIA TOTAL T-4 (RIA) TEST
K781181 · CDX
Miles Laboratories, Inc.
Chemistry · 31d
Cleared Aug 14, 1978
MICRO THYROXINE REAGENT SYSTEM
K781182 · CDX
Bd Becton Dickinson Vacutainer...
Chemistry · 31d
Cleared Aug 14, 1978
UNISTAT BILIRUBINOMETER
K781241 · JJQ
American Optical Corp.
Chemistry · 26d
Cleared Aug 11, 1978
CONJUGATED BILE ACIDS RIA KIT
K781337 · KWW
Bd Becton Dickinson Vacutainer...
Chemistry · 8d
Cleared Aug 10, 1978
TRAP-BLOOD VESSEL STABILIZATION DEVICE
K781072 · JIT
Ayer, Patrick, M.D.
Chemistry · 45d
Cleared Aug 10, 1978
ECA BUFFER, PH 816
K781116 · CEF
Electrophoresis Corp. of America
Chemistry · 38d