ACON STREP A TWIST TEST DEVICE

Antigens, All Groups, Streptococcus Spp.

ACON LABORATORIES CO.

The following data is part of a premarket notification filed by Acon Laboratories Co. with the FDA for Acon Strep A Twist Test Device.

Pre-market Notification Details

Device IDK023766
510k NumberK023766
Device Name:ACON STREP A TWIST TEST DEVICE
ClassificationAntigens, All Groups, Streptococcus Spp.
Applicant ACON LABORATORIES CO. 4108 SORRENTO VALLEY BLVD. San Diego,  CA  92121
ContactEdward Tung
CorrespondentEdward Tung
ACON LABORATORIES CO. 4108 SORRENTO VALLEY BLVD. San Diego,  CA  92121
Product CodeGTY  
CFR Regulation Number866.3740 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-11-12
Decision Date2003-02-10
Summary:summary

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