BIOTIS (TM) STARCH HYDROLYSIS WITH BCP

Culture Media, Single Biochemical Test

OTISVILLE BIOPHARM, INC.

The following data is part of a premarket notification filed by Otisville Biopharm, Inc. with the FDA for Biotis (tm) Starch Hydrolysis With Bcp.

Pre-market Notification Details

Device IDK874174
510k NumberK874174
Device Name:BIOTIS (TM) STARCH HYDROLYSIS WITH BCP
ClassificationCulture Media, Single Biochemical Test
Applicant OTISVILLE BIOPHARM, INC. P.O. BOX 567 SANATORIUM RD. Otisville,  NY  10963
ContactPat Mulholland
CorrespondentPat Mulholland
OTISVILLE BIOPHARM, INC. P.O. BOX 567 SANATORIUM RD. Otisville,  NY  10963
Product CodeJSF  
CFR Regulation Number866.2320 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-10-13
Decision Date1987-12-04

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