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FDA 510(k)

BIOTIS (TM) INHIBITORY MOLD AGAR (DOUBLE POUR)

K-Number: K874172 · 1987-10-28

ApplicantOtisville Biopharm, Inc.
Decision Date1987-10-28
Product CodeJSJ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BIOTIS (TM) INHIBITORY MOLD AGAR (DOUBLE POUR) 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 1987-10-28 under 510(k) number K874172. 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) INHIBITORY MOLD AGAR (DOUBLE POUR)?

BIOTIS (TM) INHIBITORY MOLD AGAR (DOUBLE POUR) is a medical device that received FDA 510(k) clearance on 1987-10-28. The listed applicant is Otisville Biopharm, Inc.. The 510(k) number is K874172.

When did BIOTIS (TM) INHIBITORY MOLD AGAR (DOUBLE POUR) receive FDA 510(k) clearance?

BIOTIS (TM) INHIBITORY MOLD AGAR (DOUBLE POUR) received FDA 510(k) clearance on 1987-10-28, under 510(k) number K874172.

Who is the listed applicant for BIOTIS (TM) INHIBITORY MOLD AGAR (DOUBLE POUR)?

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) INHIBITORY MOLD AGAR (DOUBLE POUR)?

The FDA product code for BIOTIS (TM) INHIBITORY MOLD AGAR (DOUBLE POUR) 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)K874175BIOTIS (TM) MUELLER HINTON W/4% SALT, 6MCG/ML OXACK874178BIOTIS (TM) BCYE SELECTIVEK874174BIOTIS (TM) STARCH HYDROLYSIS WITH BCPK874177BIOTIS (TM) BCYE

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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