BIOTIS (TM) STARCH HYDROLYSIS WITH BCP— 510(k) K874174

Name: FDA 510(k) clearance K874174
Creator: U.S. Food and Drug Administration
Published: 1987-12-04

Substantially Equivalent

Otisville Biopharm, Inc.

FDA 510(k) clearance K874174 for BIOTIS (TM) STARCH HYDROLYSIS WITH BCP, Substantially Equivalent on 1987-12-04. Applicant: Otisville Biopharm, Inc.. Device class: 1.

Clearance details

Applicant: Otisville Biopharm, Inc.
Product code: Code JSF
Device class: Class 1
Regulation: 21 CFR 866.2320
Advisory panel: Microbiology
Date received: 1987-10-13
Decision date: 1987-12-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Otisville, NY, US

Download summary PDF View on FDA.gov ↗

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K874177 — BIOTIS (TM) BCYE1987-12-04
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