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
11065–11088 of 13,224
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared May 03, 1982
SKATRON REPEATING DISPENSER
K821034 · JQW
Skatron, Inc.
Chemistry · 20d
Cleared May 03, 1982
LIQUID-STAT TM AST-UV LIQUID ENZUNE
K821048 · CKA
Beckman Instruments, Inc.
Chemistry · 18d
Cleared May 03, 1982
715 DELTA TERMINAL
K821058 · JQP
Corning Medical & Scientific
Chemistry · 18d
Cleared May 03, 1982
ACE ALBUMIN CALIBRATOR
K821061 · JIS
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 18d
Cleared Apr 29, 1982
TANDEM HCG KIT
K820822 · JHI
Hybritech, Inc.
Chemistry · 36d
Cleared Apr 26, 1982
EMIT URINE METHADONE ASSAY #3E319
K820900 · DDE
Syva Co.
Chemistry · 26d
Cleared Apr 26, 1982
NOVA III FLUIDS PACK
K820947 · JIX
Shaban Mfg. Co.
Chemistry · 20d
Cleared Apr 26, 1982
TOTAL CHOLESTEROL REAGENT SET
K820950 · CHH
Sterling Biochemical, Inc.
Chemistry · 20d
Cleared Apr 26, 1982
ENZYMATIC CHOLESTEROL KIT
K820951 · CHH
Anco Medical Reagents & Assoc.
Chemistry · 20d
Cleared Apr 26, 1982
GILCHEM ACID PHOSPHATASE REAGENT
K820975 · CKB
Gilford Diagnostics
Chemistry · 20d
Cleared Apr 26, 1982
GIL CHEM MAGNESIUM REAGENT
K820976 · JGJ
Gilford Diagnostics
Chemistry · 20d
Cleared Apr 26, 1982
ENZYMUNE-TEST DIGOXIN
K821000 · DON
Icl Scientific
Chemistry · 18d
Cleared Apr 16, 1982
LH RADIOIMMUNOASSAY TEST SYSTEM
K820760 · CEP
Monobind
Chemistry · 25d
Cleared Apr 16, 1982
CORNING CERTAIN TM
K820873 · JJS
Corning Medical & Scientific
Chemistry · 18d
Cleared Apr 16, 1982
ENZYME-TEST TBC T4 UPTAKE
K820879 · KHQ
Icl Scientific
Chemistry · 17d
Cleared Apr 16, 1982
SERALYZER CK REAGENT STRIPS
K820880 · CGS
Miles Laboratories, Inc.
Chemistry · 17d
Cleared Apr 16, 1982
THYROXINE T4 KIT
K820886 · CDX
Pcl-Ria, Inc.
Chemistry · 17d
Cleared Apr 15, 1982
IL MODEL 1301, PH BLOOD GAS SYSTEM
K820744 · CHL
Instrumentation Laboratory CO
Chemistry · 27d
Cleared Apr 15, 1982
AMERLEX ESH KIT
K820754 · CGJ
Amersham Corp.
Chemistry · 27d
Cleared Apr 15, 1982
ENZYM-LINKED T3
K820763 · CDP
Icl Scientific
Chemistry · 24d
Cleared Apr 15, 1982
PHOSPHORUS IL
K820832 · CED
American Monitor Corp.
Chemistry · 20d
Cleared Apr 14, 1982
HISTOSET IMMUNOPEROXIDASE TISSURE KIT
K820390 · LKH
Immulok, Inc.
Chemistry · 63d
Cleared Apr 14, 1982
FLUOROGEN PAP FIA
K820724 · JFH
Biogenex Laboratories
Chemistry · 28d
Cleared Apr 14, 1982
MR1 LUTROPIN RIA KIT
K820741 · CEP
Microanalytic Research, Inc.
Chemistry · 27d