SPQ(TM) TEST SYSTEM FOR MICROALBUMIN

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 Microalbumin.

Pre-market Notification Details

Device IDK884298
510k NumberK884298
Device Name:SPQ(TM) TEST SYSTEM FOR MICROALBUMIN
ClassificationPrealbumin, Antigen, Antiserum, Control
Applicant ATLANTIC ANTIBODIES 10 NONESUCH RD. P.O. BOX 60 Scarborough,  ME  04074
ContactGlenn Irish
CorrespondentGlenn Irish
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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