FDA.reportPublic FDA data

EPOCAL, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30049597933004959793EPOCAL, INC.1N2026-01-012060 Walkley Road Ottawa Ontario CA K1G-3P5

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2128871749010452K200107epoc Blood Analysis SystemCHL2020-06-05
2128871732996115K171247epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide TestCDS2018-01-17
2128871240807102K113726EPOC CHLORIDE TEST AND EPOC CREATININE TESTCGL2012-10-05
2128871822004218K093297EPOC BGEM, EPOC READER, EPOC HOST, EPOC CARE-FILL CAPILLARY TUBEKHP2010-06-09
2128871303488967K092849BLOOD COLLECTION TUBE SAMPLES FOR USE WITH POINT OF CARE BLOOD ANALYZERCEM2010-03-30
2128871143978332K090109BLOOD GAS, ELECTROLYTE AND METABOLITE TEST CARDCGA2009-06-24
2128871085836598K061597EPOC BLOOD ANALYSIS SYSTEMJGS2006-09-27
2128871376055993

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
CHL12020-06-05
CDS12018-01-17
CGL12012-10-05
KHP12010-06-09
CEM12010-03-30
CGA12009-06-24
JGS12006-09-27

PMN#