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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Chemistry ×
13,237 results
8809–8832 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Aug 12, 1986
GLUCOFACTS DATA MANAGEMENT SYSTEM
K861844 · JQP
Miles Laboratories, Inc.
Chemistry · 91d
Cleared Aug 12, 1986
MODEL 303-42/303-43 ASPARTATE AMINOTRANSFERASE KIT
K862832 · CIT
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 18d
Cleared Aug 08, 1986
GLUCOFACTS DATA PRINTER
K861779 · JQP
Miles Laboratories, Inc.
Chemistry · 92d
Cleared Aug 04, 1986
DIAGEM 300 BG REAGENT STRIPS
K854329 · CGA
Seton Products, Inc.
Chemistry · 280d
Cleared Aug 04, 1986
DIATRON BLOOD GLUCOSE METER
K855178 · CGA
Dextron, Inc.
Chemistry · 221d
Cleared Aug 04, 1986
FORETEL, COLOR OVULATION TEST
K860828 · CEP
Nms Pharmaceuticals, Inc.
Chemistry · 152d
Cleared Aug 04, 1986
LYPHOCHEK PEDIATRIC AND BILIRUBIN CONTROL
K862185 · JJY
Bio-Rad
Chemistry · 56d
Cleared Aug 04, 1986
TAURUS (TM) AUTOMATIC LIQUID SCINTILLATION COUNTER
K862206 · JJJ
Micromedic Systems
Chemistry · 55d
Cleared Aug 04, 1986
GAS-TRAK
K862278 · JJY
United Diagnostics, Inc.
Chemistry · 49d
Cleared Aug 04, 1986
PARAMAX LIPASE REAGENT
K862440 · CET
American Dade
Chemistry · 39d
Cleared Aug 04, 1986
CHEMVARION(TM)
K862586 · JJY
G.B.F. Industries, Inc.
Chemistry · 28d
Cleared Aug 04, 1986
CHEMTROL(TM)
K862587 · JJY
G.B.F. Industries, Inc.
Chemistry · 28d
Cleared Aug 04, 1986
EMDS(TM) ELEVATED LIPID CALIBRATOR #67626/95
K862703 · JIX
Em Diagnostic Systems, Inc.
Chemistry · 20d
Cleared Aug 01, 1986
DART AMYLASE-D.S. REAGENT SYSTEM
K862370 · CIJ
Coulter Electronics, Inc.
Chemistry · 38d
Cleared Jul 29, 1986
RIGHT-DAY URINARY LH (EIA)
K860538 · CEP
Leeco Diagnostics, Inc.
Chemistry · 167d
Cleared Jul 29, 1986
LEECO CONCEP-7-BHCG (EIA) II (MODIFIED)
K861703 · JHJ
Leeco Diagnostics, Inc.
Chemistry · 85d
Cleared Jul 29, 1986
TWIN GOT-AST IFCC/GPT-ALT IFCC
K861792 · CKA
Boehringer Mannheim Corp.
Chemistry · 81d
Cleared Jul 29, 1986
TARGET HCG, ENZYME IMMUNOASSAY REAGENTS
K862247 · JHI
V-Tech, Inc.
Chemistry · 47d
Cleared Jul 29, 1986
IL 482 CO-OXIMETER
K862253 · JKS
Instrumentation Laboratory CO
Chemistry · 46d
Cleared Jul 29, 1986
LACTATE DEHYDROGENASE (LDH) REAGENT SET (UV RATE)
K862255 · CFJ
Sterling Diagnostics, Inc.
Chemistry · 46d
Cleared Jul 29, 1986
HCG MAIACLONE IMMUNORADIOMETRIC KIT/KIT COMPONENTS
K862262 · JHI
Serono Diagnostics, Inc.
Chemistry · 46d
Cleared Jul 29, 1986
ANALYST ANALYTICAL TEST ROTORS
K862274 · CIC
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 43d
Cleared Jul 29, 1986
AMRESCO FLOW PAC SODIUM POTASSIUM REAGENT
K862300 · JGM
Amresco, Inc.
Chemistry · 42d
Cleared Jul 25, 1986
ADDITIONAL KYOTEST URINE TEST REAGENT STRIPS
K861733 · JIL
Kyoto Diagnostics, Inc.
Chemistry · 80d