IMFECTIOUS MONONUCLEOSIS IM LIQUID CARD TEST

System, Test, Infectious Mononucleosis

AMPCOR, INC.

The following data is part of a premarket notification filed by Ampcor, Inc. with the FDA for Imfectious Mononucleosis Im Liquid Card Test.

Pre-market Notification Details

Device IDK922296
510k NumberK922296
Device Name:IMFECTIOUS MONONUCLEOSIS IM LIQUID CARD TEST
ClassificationSystem, Test, Infectious Mononucleosis
Applicant AMPCOR, INC. 510 HERON DRIVE, BLDG 306 P.O. BOX 521 Bridgeport,  NJ  08014
ContactMartin R Gould
CorrespondentMartin R Gould
AMPCOR, INC. 510 HERON DRIVE, BLDG 306 P.O. BOX 521 Bridgeport,  NJ  08014
Product CodeKTN  
CFR Regulation Number866.5640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-05-15
Decision Date1992-07-14

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