SPQ(TM) TEST SYSTEM FOR PREALBUMIN

Prealbumin, Antigen, Antiserum, Control

ATLANTIC ANTIBODIES

The following data is part of a premarket notification filed by Atlantic Antibodies with the FDA for Spq(tm) Test System For Prealbumin.

Pre-market Notification Details

Device IDK884297
510k NumberK884297
Device Name:SPQ(TM) TEST SYSTEM FOR PREALBUMIN
ClassificationPrealbumin, Antigen, Antiserum, Control
Applicant ATLANTIC ANTIBODIES 10 NONESUCH RD. P.O. BOX 60 Scarborough,  ME  04074
ContactThomas Snyder
CorrespondentThomas Snyder
ATLANTIC ANTIBODIES 10 NONESUCH RD. P.O. BOX 60 Scarborough,  ME  04074
Product CodeJZJ  
CFR Regulation Number866.5060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-10-12
Decision Date1988-11-02

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