SPOTTEST MICRODASE

Discs, Strips And Reagents, Microorganism Differentiation

DIFCO LABORATORIES, INC.

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

Pre-market Notification Details

Device IDK870717
510k NumberK870717
Device Name:SPOTTEST MICRODASE
ClassificationDiscs, Strips And Reagents, Microorganism Differentiation
Applicant DIFCO LABORATORIES, INC. P.O. BOX 331058 Detroit,  MI  48232 -7058
ContactM. T Robert
CorrespondentM. T Robert
DIFCO LABORATORIES, INC. P.O. BOX 331058 Detroit,  MI  48232 -7058
Product CodeJTO  
CFR Regulation Number866.2660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-02-20
Decision Date1987-04-03

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