SPQ TM TEST SYSTEM II FOR CRP

C-reactive Protein, Antigen, Antiserum, And Control

ATLANTIC ANTIBODIES

The following data is part of a premarket notification filed by Atlantic Antibodies with the FDA for Spq Tm Test System Ii For Crp.

Pre-market Notification Details

Device IDK892526
510k NumberK892526
Device Name:SPQ TM TEST SYSTEM II FOR CRP
ClassificationC-reactive Protein, Antigen, Antiserum, And 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 CodeDCK  
CFR Regulation Number866.5270 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-04-11
Decision Date1989-05-09

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