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
11977–12000 of 13,249
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
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
Cleared Mar 19, 1980
T3 SOLID PHASE RADIOIMMUNOASSAY KIT
K800436 · CDP
Bd Becton Dickinson Vacutainer...
Chemistry · 21d
Cleared Mar 12, 1980
CENTRIFICHEM FILTER CALIBRATION SET
K800304 · JIW
Union Carbide Corp.
Chemistry · 29d
Cleared Mar 12, 1980
BUN REAGENT
K800341 · CDQ
Gilford Diagnostics
Chemistry · 26d
Cleared Mar 12, 1980
CK/LD ISOENZYME CONTROL PROD. #ACS CT101
K800370 · JJY
Analytical Control Systems, Inc.
Chemistry · 21d
Cleared Mar 12, 1980
AMERLEX T-3 RIA KIT
K800374 · CDP
Amersham Corp.
Chemistry · 20d
Cleared Mar 05, 1980
DATA MANAGEMENT SYSTEM IL MODEL 775
K800282 · JQP
Instrumentation Laboratory CO
Chemistry · 26d