SPQ TEST SYSTEM FOR C-REACTIVE PROTEIN

C-reactive Protein, Antigen, Antiserum, And Control

APPLICATIONS LAB

The following data is part of a premarket notification filed by Applications Lab with the FDA for Spq Test System For C-reactive Protein.

Pre-market Notification Details

Device IDK850590
510k NumberK850590
Device Name:SPQ TEST SYSTEM FOR C-REACTIVE PROTEIN
ClassificationC-reactive Protein, Antigen, Antiserum, And 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 CodeDCK  
CFR Regulation Number866.5270 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-02-13
Decision Date1985-03-01

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