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
10561–10584 of 13,224
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Apr 12, 1983
AMES TDA VALPROIC ACID TEST
K830789 · LEG
Miles Laboratories, Inc.
Chemistry · 29d
Cleared Apr 12, 1983
DSL 1900
K830816 · CGI
Diagnostic Systems
Chemistry · 28d
Cleared Apr 12, 1983
NEGATIVE URINE CONTROL
K830834 · JJW
Helena Laboratories
Chemistry · 27d
Cleared Apr 12, 1983
TITAN GEL LDH ISO-ENZYME CONTROL
K830872 · CFE
Helena Laboratories
Chemistry · 25d
Cleared Apr 12, 1983
TDX T-UPTAKE
K830912 · KHQ
Abbott Laboratories
Chemistry · 22d
Cleared Apr 08, 1983
LEECO DIG-QUANT DIAG. TEST KIT
K830785
Leeco Diagnostics, Inc.
Chemistry · 28d
Cleared Apr 08, 1983
KNAI SODIUM POTASSIUM ANALYZER
K830805 · JSG
Radiometer America, Inc.
Chemistry · 25d
Cleared Apr 08, 1983
LEECO T3-RIA DIAGNOSTIC KIT
K830808 · CDP
Leeco Diagnostics, Inc.
Chemistry · 25d
Cleared Apr 06, 1983
GLUCOSE REAGENT
K823537 · FMF
Ac Biochemical Laboratories, Inc.
Chemistry · 127d
Cleared Apr 06, 1983
URIC ACID COLORIMETRIC DETERMINATION
K830679 · KNK
Dow Instruments & Reagents, Inc.
Chemistry · 33d
Cleared Apr 06, 1983
TDX THYROXINE
K830683 · KLI
Abbott Laboratories
Chemistry · 33d
Cleared Apr 06, 1983
MMH PTH RIA KIT
K830700 · CEW
Diagnostic Systems
Chemistry · 30d
Cleared Apr 06, 1983
TOTAL BILIRUBIN REAGENT
K830714 · CIG
Hi Chem, Inc.
Chemistry · 29d
Cleared Apr 06, 1983
KEMTEK 102
K830751 · JJJ
Kemble Instruments, Inc.
Chemistry · 27d
Cleared Apr 05, 1983
PHADEBAS HUMYLASE CONTROL(H)
K823421 · JJX
Pharmacia, Inc.
Chemistry · 138d
Cleared Apr 05, 1983
ELISA PLUS SYSTEM
K830212 · JJE
William-Palmer Industries, Inc.
Chemistry · 71d
Cleared Apr 05, 1983
NOVA 7 TOTAL CALCIUM/IONIZED CALCIUM
K830213 · JFP
Nova Biomedical Corp.
Chemistry · 71d
Cleared Apr 05, 1983
ULTRA CHEM ENZYMATIC CHOLESTEROL OXIDA
K830239 · CHH
Emd Chemicals, Inc.
Chemistry · 70d
Cleared Apr 05, 1983
ULTRA CHEM BUN-UV #65080-65081
K830241 · CDQ
Emd Chemicals, Inc.
Chemistry · 70d
Cleared Apr 05, 1983
RADIOIMMUNOASSAY TEST SYSTEM PRL
K830412 · CFT
Monobind
Chemistry · 56d
Cleared Apr 05, 1983
LEECO TESTOSTERONE DIAGNOSTIC KIT
K830512 · CDZ
Leeco Diagnostics, Inc.
Chemistry · 47d
Cleared Apr 05, 1983
B-GCG SYSTEM BY RIA
K830526 · JHI
Pcl-Ria, Inc.
Chemistry · 47d
Cleared Apr 05, 1983
PHASE II DIGOXIN RADIOIMMUNOASSAY KIT
K830533 · DON
Medical & Scientific Designs, Inc.
Chemistry · 46d
Cleared Apr 05, 1983
ACTIVATED URIC ACID
K830616 · CHD
American Monitor Corp.
Chemistry · 36d