CAMPYLOBACTER SUPPLEMENT -SKIRROW

Supplement, Culture Media

PRO-LAB, INC.

The following data is part of a premarket notification filed by Pro-lab, Inc. with the FDA for Campylobacter Supplement -skirrow.

Pre-market Notification Details

Device IDK850306
510k NumberK850306
Device Name:CAMPYLOBACTER SUPPLEMENT -SKIRROW
ClassificationSupplement, Culture Media
Applicant PRO-LAB, INC. 76 GLENGARRY AVENUE TORONTO Ontario Canada M5m 1c9,  CA
ContactLynn Rae
CorrespondentLynn Rae
PRO-LAB, INC. 76 GLENGARRY AVENUE TORONTO Ontario Canada M5m 1c9,  CA
Product CodeJSK  
CFR Regulation Number866.2450 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-01-22
Decision Date1985-03-20

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