CULTURESWAB TRANSPORT SYSTEM

System, Transport, Aerobic

DIFCO LABORATORIES, INC.

The following data is part of a premarket notification filed by Difco Laboratories, Inc. with the FDA for Cultureswab Transport System.

Pre-market Notification Details

Device IDK934894
510k NumberK934894
Device Name:CULTURESWAB TRANSPORT SYSTEM
ClassificationSystem, Transport, Aerobic
Applicant DIFCO LABORATORIES, INC. P.O. BOX 331058 Detroit,  MI  48232 -7058
ContactDavid W Gates
CorrespondentDavid W Gates
DIFCO LABORATORIES, INC. P.O. BOX 331058 Detroit,  MI  48232 -7058
Product CodeJTW  
CFR Regulation Number866.2900 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-10-05
Decision Date1994-02-22

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