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.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Chemistry ×
13,224 results
11377–11400 of 13,224
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jul 23, 1981
KING DIAGNOSTICS TOTAL BILIRUBIN TEST
K811881 · CIG
King Diagnostics, Inc.
Chemistry · 22d
Cleared Jul 23, 1981
KING DIAGNOSTICS GLUCOSE TEST
K811882 · CGA
King Diagnostics, Inc.
Chemistry · 22d
Cleared Jul 23, 1981
KING DIAGNOSTICS GLUCOSE-O TEST
K811883 · CGE
King Diagnostics, Inc.
Chemistry · 22d
Cleared Jul 23, 1981
CESIUM DILUENT 7.5M
K811886 · JGT
Gilford Diagnostics
Chemistry · 22d
Cleared Jul 23, 1981
902 NA/K
K811896 · JGS
Corning Medical & Scientific
Chemistry · 22d
Cleared Jul 23, 1981
FOLLICLE STIMULATING HORMONE DIRECT RIA
K811905 · CGJ
Immunalysis Corporation
Chemistry · 22d
Cleared Jul 23, 1981
DHEA-SULFATE DIRECT RIA KIT(125I)
K811906 · JKC
Immunalysis Corporation
Chemistry · 22d
Cleared Jul 23, 1981
PROGESTERONE DIRECT RIA KIT (125I)
K811907 · JLS
Immunalysis Corporation
Chemistry · 22d
Cleared Jul 23, 1981
HELENA VMA-SMC CONTROL
K811912 · JJX
Helena Laboratories
Chemistry · 22d
Cleared Jul 23, 1981
KODAK EKTACHEM 400 ANALYZER
K811919 · JJE
Eastman Kodak Company
Chemistry · 21d
Cleared Jul 23, 1981
HITACHI 705 CALIBRATOR
K811921 · JIX
Boehringer Mannheim Corp.
Chemistry · 21d
Cleared Jul 23, 1981
COAT-A-COUNT DIGOXIN RIA
K811932 · DPO
Diagnostic Products Corp.
Chemistry · 17d
Cleared Jul 15, 1981
DRUG STANDARDS
K811674 · DKB
Supelco, Inc.
Chemistry · 30d
Cleared Jul 15, 1981
QUICK-CHEM COLORIMETER
K811806 · JJQ
The Dow Chemical Co.
Chemistry · 20d
Cleared Jul 15, 1981
URIC ACID TEST
K811810 · KNK
Environmental Chemical Specialties
Chemistry · 20d
Cleared Jul 15, 1981
PRECINORM U & PRECIPATH U HUMAN SERUM
K811832 · JJX
Boehringer Mannheim Corp.
Chemistry · 16d
Cleared Jul 15, 1981
BILIRUBINOMETER
K811840 · JJQ
Advanced Instruments, Inc.
Chemistry · 14d
Cleared Jul 15, 1981
ESKAFLOW TEST FOR GLUCOSE
K811849 · CFR
Smithkline Diagnostics, Inc.
Chemistry · 14d
Cleared Jul 10, 1981
BUN RATE REAGENT
K811193 · CDS
Chem-Elec, Inc.
Chemistry · 71d
Cleared Jul 10, 1981
SODIUM/POTASSIUM REAGENT KITS
K811310 · CEM
Chem-Elec, Inc.
Chemistry · 60d
Cleared Jul 10, 1981
HCG RADIOIMMUNOASSAY KIT (125I)
K811421 · JHI
Bd Becton Dickinson Vacutainer...
Chemistry · 51d
Cleared Jul 10, 1981
VENTRE/SEP IGE RIA TEST SET
K811559 · DGC
Ventrex Laboratories, Inc.
Chemistry · 38d
Cleared Jul 10, 1981
B-D DRAKE WILLOCK #7000 SERIES ULTRAF
K811591 · FKP
Bd Becton Dickinson Vacutainer...
Chemistry · 32d
Cleared Jul 10, 1981
QUANTIMUNE ESTRIOL RIA
K811709 · CGI
Bio-Rad
Chemistry · 23d