VIROTROL III

Multi-analyte Controls, All Kinds (assayed)

BLACKHAWK BIOSYSTEMS, INC.

The following data is part of a premarket notification filed by Blackhawk Biosystems, Inc. with the FDA for Virotrol Iii.

Pre-market Notification Details

Device IDK974613
510k NumberK974613
Device Name:VIROTROL III
ClassificationMulti-analyte Controls, All Kinds (assayed)
Applicant BLACKHAWK BIOSYSTEMS, INC. 12945 ALCOSTA BLVD. San Ramon,  CA  94583
ContactCarole Polito
CorrespondentCarole Polito
BLACKHAWK BIOSYSTEMS, INC. 12945 ALCOSTA BLVD. San Ramon,  CA  94583
Product CodeJJY  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-12-11
Decision Date1998-01-27

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