CAMPY 3

Culture Media, Selective And Non-differential

HARDY MEDIA

The following data is part of a premarket notification filed by Hardy Media with the FDA for Campy 3.

Pre-market Notification Details

Device IDK834313
510k NumberK834313
Device Name:CAMPY 3
ClassificationCulture Media, Selective And Non-differential
Applicant HARDY MEDIA 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJSJ  
CFR Regulation Number866.2360 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-12-09
Decision Date1984-01-13

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