SPQ(TM) ANTIBODY REAGENT SET II FOR AAT

Alpha-1-antitrypsin, Antigen, Antiserum, Control

ATLANTIC ANTIBODIES

The following data is part of a premarket notification filed by Atlantic Antibodies with the FDA for Spq(tm) Antibody Reagent Set Ii For Aat.

Pre-market Notification Details

Device IDK890415
510k NumberK890415
Device Name:SPQ(TM) ANTIBODY REAGENT SET II FOR AAT
ClassificationAlpha-1-antitrypsin, 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 CodeDEM  
CFR Regulation Number866.5130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-01-24
Decision Date1989-02-17

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