SPQ TEST SYSTEM FOR ALPHA, - ANTITRYPSIN

Alpha-1-antitrypsin, Antigen, Antiserum, Control

APPLICATIONS LAB

The following data is part of a premarket notification filed by Applications Lab with the FDA for Spq Test System For Alpha, - Antitrypsin.

Pre-market Notification Details

Device IDK850587
510k NumberK850587
Device Name:SPQ TEST SYSTEM FOR ALPHA, - ANTITRYPSIN
ClassificationAlpha-1-antitrypsin, Antigen, Antiserum, Control
Applicant APPLICATIONS LAB 10 NONESUCH RD. Scarborough,  ME  04074
ContactGlenn R Irish
CorrespondentGlenn R Irish
APPLICATIONS LAB 10 NONESUCH RD. Scarborough,  ME  04074
Product CodeDEM  
CFR Regulation Number866.5130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-02-13
Decision Date1985-03-14

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