MYCOPLASMA HYORHINIS (BTS-7)

Media And Components, Mycoplasma Detection

FLOW LABORATORIES, INC.

The following data is part of a premarket notification filed by Flow Laboratories, Inc. with the FDA for Mycoplasma Hyorhinis (bts-7).

Pre-market Notification Details

Device IDK781390
510k NumberK781390
Device Name:MYCOPLASMA HYORHINIS (BTS-7)
ClassificationMedia And Components, Mycoplasma Detection
Applicant FLOW LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeKPB  
CFR Regulation Number864.2360 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1978-08-10
Decision Date1978-09-01

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