HISTO-CHECK LEGIONELLA CONTROL SLIDES

Quality Control Slides

VAL TECH DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Val Tech Diagnostics, Inc. with the FDA for Histo-check Legionella Control Slides.

Pre-market Notification Details

Device IDK883567
510k NumberK883567
Device Name:HISTO-CHECK LEGIONELLA CONTROL SLIDES
ClassificationQuality Control Slides
Applicant VAL TECH DIAGNOSTICS, INC. 14 WERNER CAMP RD. Pittsburgh,  PA  15215
ContactSteve L Sinka
CorrespondentSteve L Sinka
VAL TECH DIAGNOSTICS, INC. 14 WERNER CAMP RD. Pittsburgh,  PA  15215
Product CodeLJG  
CFR Regulation Number866.2660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-08-22
Decision Date1988-10-06

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