ACON MONONUCLEOSIS RAPID TEST STRIP (WHOLE BLOOD/SERUM/PLASMA)

System, Test, Infectious Mononucleosis

ACON LABORATORIES, INC.

The following data is part of a premarket notification filed by Acon Laboratories, Inc. with the FDA for Acon Mononucleosis Rapid Test Strip (whole Blood/serum/plasma).

Pre-market Notification Details

Device IDK042272
510k NumberK042272
Device Name:ACON MONONUCLEOSIS RAPID TEST STRIP (WHOLE BLOOD/SERUM/PLASMA)
ClassificationSystem, Test, Infectious Mononucleosis
Applicant ACON LABORATORIES, INC. 4108 SORRENTO VALLEY BLVD. San Diego,  CA  92121
ContactEdward Tung, Ph.d.
CorrespondentEdward Tung, Ph.d.
ACON LABORATORIES, INC. 4108 SORRENTO VALLEY BLVD. San Diego,  CA  92121
Product CodeKTN  
CFR Regulation Number866.5640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-08-23
Decision Date2005-02-28
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00722066000311 K042272 000

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