PASCO MIC AND MIC/ID PANELS

Susceptibility Test Powders, Antimicrobial

PASCO LABORATORIES, INC.

The following data is part of a premarket notification filed by Pasco Laboratories, Inc. with the FDA for Pasco Mic And Mic/id Panels.

Pre-market Notification Details

Device IDK935805
510k NumberK935805
Device Name:PASCO MIC AND MIC/ID PANELS
ClassificationSusceptibility Test Powders, Antimicrobial
Applicant PASCO LABORATORIES, INC. 12750 WEST 42ND AVE. Wheat Ridge,  CO  80033
ContactLinda K Dillon
CorrespondentLinda K Dillon
PASCO LABORATORIES, INC. 12750 WEST 42ND AVE. Wheat Ridge,  CO  80033
Product CodeJTT  
CFR Regulation Number866.1640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-12-02
Decision Date1994-06-13

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