SERODIA TP-PA

Antigens, Ha, Treponema Pallidum

SCIMEDX TEKFILE SERVICES

The following data is part of a premarket notification filed by Scimedx Tekfile Services with the FDA for Serodia Tp-pa.

Pre-market Notification Details

Device IDK971502
510k NumberK971502
Device Name:SERODIA TP-PA
ClassificationAntigens, Ha, Treponema Pallidum
Applicant SCIMEDX TEKFILE SERVICES 400 FORD RD. Denvill,  NJ  07834
ContactGary Lehnus
CorrespondentGary Lehnus
SCIMEDX TEKFILE SERVICES 400 FORD RD. Denvill,  NJ  07834
Product CodeGMT  
CFR Regulation Number866.3830 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-04-24
Decision Date1997-11-13

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00850212007027 K971502 000
00850212007010 K971502 000
00869164000062 K971502 000
00869164000055 K971502 000

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