ADI SYPHILIS RPR LIQUID CONTROLS

Antisera, Control For Nontreponemal Tests

AMPCOR DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Ampcor Diagnostics, Inc. with the FDA for Adi Syphilis Rpr Liquid Controls.

Pre-market Notification Details

Device IDK980638
510k NumberK980638
Device Name:ADI SYPHILIS RPR LIQUID CONTROLS
ClassificationAntisera, Control For Nontreponemal Tests
Applicant AMPCOR DIAGNOSTICS, INC. 603 HERON DR., BLDG. 3 Bridgeport,  NJ  08104
ContactRaymond Miller
CorrespondentRaymond Miller
AMPCOR DIAGNOSTICS, INC. 603 HERON DR., BLDG. 3 Bridgeport,  NJ  08104
Product CodeGMP  
CFR Regulation Number866.3820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-02-19
Decision Date1998-07-06

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00382902769095 K980638 000

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