IMMUNOGLOBULINS A,G,M,D,E IMMUNOLOGICAL TEST

Iga, Antigen, Antiserum, Control

ATLANTIC ANTIBODIES

The following data is part of a premarket notification filed by Atlantic Antibodies with the FDA for Immunoglobulins A,g,m,d,e Immunological Test.

Pre-market Notification Details

Device IDK861167
510k NumberK861167
Device Name:IMMUNOGLOBULINS A,G,M,D,E IMMUNOLOGICAL TEST
ClassificationIga, Antigen, Antiserum, Control
Applicant ATLANTIC ANTIBODIES 10 NONESUCH RD. P.O. BOX 60 Scarborough,  ME  04074
ContactGlenn R Irish
CorrespondentGlenn R Irish
ATLANTIC ANTIBODIES 10 NONESUCH RD. P.O. BOX 60 Scarborough,  ME  04074
Product CodeCZP  
CFR Regulation Number866.5510 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-03-28
Decision Date1986-04-25

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