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FDA 510(k)

BIOTIS (TM) BCYE SELECTIVE

K-Number: K874178 · 1987-12-04

ApplicantOtisville Biopharm, Inc.
Decision Date1987-12-04
Product CodeJSJ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BIOTIS (TM) BCYE SELECTIVE is the device name listed in this FDA 510(k) record. The listed applicant is Otisville Biopharm, Inc.. It received FDA 510(k) clearance on 1987-12-04 under 510(k) number K874178. The device is classified under product code JSJ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOTIS (TM) BCYE SELECTIVE?

BIOTIS (TM) BCYE SELECTIVE is a medical device that received FDA 510(k) clearance on 1987-12-04. The listed applicant is Otisville Biopharm, Inc.. The 510(k) number is K874178.

When did BIOTIS (TM) BCYE SELECTIVE receive FDA 510(k) clearance?

BIOTIS (TM) BCYE SELECTIVE received FDA 510(k) clearance on 1987-12-04, under 510(k) number K874178.

Who is the listed applicant for BIOTIS (TM) BCYE SELECTIVE?

The FDA 510(k) record lists Otisville Biopharm, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIOTIS (TM) BCYE SELECTIVE?

The FDA product code for BIOTIS (TM) BCYE SELECTIVE is JSJ.

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Other records listing Otisville Biopharm, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K874176BIOTIS (TM) HAEMOPHILUS DUCREYIK874179BIOTIS (TM) SABHI (DOUBLE POUR)K874174BIOTIS (TM) STARCH HYDROLYSIS WITH BCPK874177BIOTIS (TM) BCYEK874175BIOTIS (TM) MUELLER HINTON W/4% SALT, 6MCG/ML OXACK874173BIOTIS (TM) BHI WITH HRBC, CHLORA/GENTAM/CYCLOHEXI

View all 8 devices →

Related Devices (Code: JSJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K882463POTATO DEXTROSE AGAR (PDA) - PRODUCT #P3421Lakewood Biochemical Co., Inc.K881544LITTMAN AGARAcumedia Manufacturers, Inc.K881561TERGITOL 7 BROTHAcumedia Manufacturers, Inc.K881526CHAPMAN STONE MEDIUMAcumedia Manufacturers, Inc.K881571YM BROTHAcumedia Manufacturers, Inc.K881578STREPTOSELAcumedia Manufacturers, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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