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
11617–11640 of 13,224
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jan 28, 1981
NUCLI-PAP TM-(I125)-PAP RADIOIMMUNOAS-
K802886 · JFH
Nuclear Diagnostics, Inc.
Chemistry · 72d
Cleared Jan 28, 1981
OMEGA THERAPEUTIC DRUG MONIT. CONTROL S.
K810077 · DIF
Hyland Therapeutic Div., Travenol...
Chemistry · 15d
Cleared Jan 28, 1981
LDH-L LIQUID ENZYMATIC, KINETIC KIT
K810083 · CFJ
Bio-Analytics Laboratories, Inc.
Chemistry · 15d
Cleared Jan 28, 1981
IRON KIT
K810085 · CFM
Bio-Analytics Laboratories, Inc.
Chemistry · 15d
Cleared Jan 28, 1981
IRON & TICB
K810086 · JQF
Bio-Analytics Laboratories, Inc.
Chemistry · 15d
Cleared Jan 28, 1981
URIC ACID (TPTZ) COLORINMETRIC
K810088 · CDH
Bio-Analytics Laboratories, Inc.
Chemistry · 15d
Cleared Jan 26, 1981
SRD III
K810022 · JTC
Dynatech Corp.
Chemistry · 21d
Cleared Jan 26, 1981
AUTOMATIC BIOCHEMICAL ANALYZER
K810063 · JQP
Acculab
Chemistry · 13d
Cleared Jan 26, 1981
ALKALINE PHOSPH., LIQUID ENZY., KIN. KIT
K810082 · CJE
Bio-Analytics Laboratories, Inc.
Chemistry · 13d
Cleared Jan 26, 1981
MAGNESIUM KIT
K810084 · JGJ
Bio-Analytics Laboratories, Inc.
Chemistry · 13d
Cleared Jan 26, 1981
6% ORTHO LOLIUDINE REAGENT IN GLACID ACI
K810089 · CGE
Anco Medical Reagents & Assoc.
Chemistry · 13d
Cleared Jan 26, 1981
CHOLESTEROL REAGENT
K810090 · CGO
Anco Medical Reagents & Assoc.
Chemistry · 13d
Cleared Jan 26, 1981
GLUCOSE STANDARD
K810091 · JIS
Anco Medical Reagents & Assoc.
Chemistry · 13d
Cleared Jan 26, 1981
RESPA-TROL
K810107 · JJS
Intensive Technology, Inc.
Chemistry · 10d
Cleared Jan 21, 1981
IMMUNOREACTIVE ESTRIOL RIA KIT
K802754 · CGI
Microanalytic Research, Inc.
Chemistry · 79d
Cleared Jan 21, 1981
ACRODISC FILTER ASSEMBLY
K802765 · FPB
Gelman Sciences, Inc.
Chemistry · 78d
Cleared Jan 21, 1981
NORMAL AND ELEVATED CONTROL FOR GLYCO.
K803186 · LCP
Applied Clinical Research Laboratories
Chemistry · 36d
Cleared Jan 21, 1981
LUTEINIZING HORMONE RADIOIMMUNOASSAY KIT
K803278 · CEP
Immuno Nuclear Corp.
Chemistry · 23d
Cleared Jan 21, 1981
'NO-BOIL' FOLIC ACID KIT
K810003
Diagnostic Products Corp.
Chemistry · 15d
Cleared Jan 21, 1981
CORTI-SHURE
K810033 · CGR
Nuclear Medical Laboratories, Inc.
Chemistry · 15d
Cleared Jan 16, 1981
AUTOMATED IMMUOCHEMISTRY SYSTEM
K803267 · JJE
Beckman Instruments, Inc.
Chemistry · 18d
Cleared Jan 16, 1981
PROLACTIN (125) RADIOIMMUNAOASSAY
K803273 · CFT
Corning Medical & Scientific
Chemistry · 18d
Cleared Jan 16, 1981
FOLLICE STIMULATING HORMONE-RADIOIMM. KT
K803279 · CGJ
Immuno Nuclear Corp.
Chemistry · 18d
Cleared Jan 16, 1981
HUMAN GROWTH HORMONE-RADIOIMM. KIT
K803280 · CFL
Immuno Nuclear Corp.
Chemistry · 18d