QUIK-DOT TOXOPLASMOSIS

Direct Agglutination Test, Toxoplasma Gondii

AMPCOR, INC.

The following data is part of a premarket notification filed by Ampcor, Inc. with the FDA for Quik-dot Toxoplasmosis.

Pre-market Notification Details

Device IDK890048
510k NumberK890048
Device Name:QUIK-DOT TOXOPLASMOSIS
ClassificationDirect Agglutination Test, Toxoplasma Gondii
Applicant AMPCOR, INC. 510 HERON DRIVE, BLDG 306 P.O. BOX 521 Bridgeport,  NJ  08014
ContactRaymond Gould
CorrespondentRaymond Gould
AMPCOR, INC. 510 HERON DRIVE, BLDG 306 P.O. BOX 521 Bridgeport,  NJ  08014
Product CodeLLA  
CFR Regulation Number866.3780 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-01-06
Decision Date1989-06-09

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