CRYOCHECK LA SURE, MODEL SUR25-10

Reagent, Russel Viper Venom

PRECISION BIOLOGIC

The following data is part of a premarket notification filed by Precision Biologic with the FDA for Cryocheck La Sure, Model Sur25-10.

Pre-market Notification Details

Device IDK990580
510k NumberK990580
Device Name:CRYOCHECK LA SURE, MODEL SUR25-10
ClassificationReagent, Russel Viper Venom
Applicant PRECISION BIOLOGIC 900 WINDMILL RD., SUITE 100 Dartmouth, N.s.,  CA B3b 1p7
ContactSandy Morrison
CorrespondentSandy Morrison
PRECISION BIOLOGIC 900 WINDMILL RD., SUITE 100 Dartmouth, N.s.,  CA B3b 1p7
Product CodeGIR  
CFR Regulation Number864.8950 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-02-23
Decision Date1999-07-28

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00843876000480 K990580 000

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