LUPO-TEST REGEANT

Reagent, Russel Viper Venom

GRAOIPORE LTD.

The following data is part of a premarket notification filed by Graoipore Ltd. with the FDA for Lupo-test Regeant.

Pre-market Notification Details

Device IDK922326
510k NumberK922326
Device Name:LUPO-TEST REGEANT
ClassificationReagent, Russel Viper Venom
Applicant GRAOIPORE LTD. 200 HARRIS ST. SYDNEY NSW 2009, P.O. BOX 65 Pyrmont 2009 Australia,  AU
ContactManusu
CorrespondentManusu
GRAOIPORE LTD. 200 HARRIS ST. SYDNEY NSW 2009, P.O. BOX 65 Pyrmont 2009 Australia,  AU
Product CodeGIR  
CFR Regulation Number864.8950 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-05-11
Decision Date1993-04-06

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00842768007477 K922326 000

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