SPQ TEST SYSTEM FOR IMMUNOGLOBULIN M

Igm (mu Chain Specific), 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 Immunoglobulin M.

Pre-market Notification Details

Device IDK850586
510k NumberK850586
Device Name:SPQ TEST SYSTEM FOR IMMUNOGLOBULIN M
ClassificationIgm (mu Chain Specific), 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 CodeDAO  
CFR Regulation Number866.5550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-02-13
Decision Date1985-03-14

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