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
11953–11976 of 13,231
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Apr 04, 1980
BUN KIT
K800590 · CDS
Nobel Scientific Industries, Inc.
Chemistry · 18d
Cleared Apr 04, 1980
VENTRE/SEP CORTISOL RIA
K800594 · CGR
Ventrex Laboratories, Inc.
Chemistry · 18d
Cleared Apr 02, 1980
SERALYZER REFLECTANCE PHOTOMETER/CALIB.
K800524 · CIE
Miles Laboratories, Inc.
Chemistry · 27d
Cleared Apr 02, 1980
LIPASE DETERMINATION
K800550 · CFG
The Dow Chemical Co.
Chemistry · 23d
Cleared Apr 02, 1980
KDA MICRO CHEMICAL ANALYZER
K800572 · JJE
American Monitor Corp.
Chemistry · 19d
Cleared Apr 02, 1980
NSI CREATININE KIT
K800583 · CGX
Nobel Scientific Industries, Inc.
Chemistry · 16d
Cleared Apr 02, 1980
NSI SODIUM/POTASSIUM KIT
K800584 · JGS
Nobel Scientific Industries, Inc.
Chemistry · 16d
Cleared Apr 02, 1980
NSI CHLORIDE REAGENT KIT
K800585 · JFS
Nobel Scientific Industries, Inc.
Chemistry · 16d
Cleared Mar 25, 1980
MAGNESIUM REAGENT
K800327 · JGJ
Alta Diagnostics, Inc.
Chemistry · 42d
Cleared Mar 25, 1980
MICRO ELISA AUTO READER
K800522 · JJQ
Dynatech Laboratories, Inc.
Chemistry · 19d
Cleared Mar 25, 1980
TRIGLYCERIDES TEST (500NM)
K800551 · JGY
Reagents Applications, Inc.
Chemistry · 15d
Cleared Mar 25, 1980
LIPID CONTROL PRODUCT # ACS LC 101
K800558 · JJY
Analytical Control Systems, Inc.
Chemistry · 13d
Cleared Mar 25, 1980
SERTROL PRODUCT # ACS ST 101
K800559 · JJY
Analytical Control Systems, Inc.
Chemistry · 13d
Cleared Mar 20, 1980
PHOTOVOLT PVA 4M+2 ANALYZER
K800453 · JJC
Photovolt Corp.
Chemistry · 20d
Cleared Mar 20, 1980
LIQUID-STAT LIQUID REAGENT
K800457 · CHH
Beckman Instruments, Inc.
Chemistry · 20d
Cleared Mar 20, 1980
MONEL 80&90 ULTRAVIOLET-VISIBLE SPEC.
K800523 · JJQ
Varian Assoc., Inc.
Chemistry · 14d
Cleared Mar 20, 1980
CENTRIFICHEM BUN
K800529 · CDQ
Union Carbide Corp.
Chemistry · 13d
Cleared Mar 20, 1980
CORNING TRANSPHOR
K800544 · JHX
Corning Medical & Scientific
Chemistry · 10d
Cleared Mar 19, 1980
RIA PHASE T4
K800203 · CDX
Boehringer Mannheim Corp.
Chemistry · 49d
Cleared Mar 19, 1980
RIA PHASE TBG
K800204 · CEE
Boehringer Mannheim Corp.
Chemistry · 49d
Cleared Mar 19, 1980
RIA PHASE DIGOXIN
K800205 · DPO
Boehringer Mannheim Corp.
Chemistry · 49d
Cleared Mar 19, 1980
REFRIG. CENTRIFUGE (DRUCKER MODEL)
K800381 · JQC
Coulter Electronics, Inc.
Chemistry · 26d
Cleared Mar 19, 1980
SMAC SYSTEM, T4 METHOD
K800384 · KLI
Technicon Instruments Corp.
Chemistry · 26d
Cleared Mar 19, 1980
ANALYTE T4-THYROXINE
K800385 · CDX
Technicon Instruments Corp.
Chemistry · 26d