PASCO MIC AND MIC/ID PANELS, LEVOFLOXACIN

Susceptibility Test Discs, 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, Levofloxacin.

Pre-market Notification Details

Device IDK992297
510k NumberK992297
Device Name:PASCO MIC AND MIC/ID PANELS, LEVOFLOXACIN
ClassificationSusceptibility Test Discs, 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 CodeJTN  
CFR Regulation Number866.1620 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-07-07
Decision Date1999-09-03
Summary:summary

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