SPQ(TM) ANTIBODY REAGENT SET II FOR IGM

Radioimmunoassay, Immunoglobulins (g, A, M)

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 Igm.

Pre-market Notification Details

Device IDK890561
510k NumberK890561
Device Name:SPQ(TM) ANTIBODY REAGENT SET II FOR IGM
ClassificationRadioimmunoassay, Immunoglobulins (g, A, M)
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 CodeCFQ  
CFR Regulation Number866.5510 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-01-24
Decision Date1989-02-23

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.