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FDA 510(k)

BIOTIS (TM) BHI WITH HRBC, CHLORA/GENTAM/CYCLOHEXI

K-Number: K874173 · 1987-10-28

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

Device Summary

BIOTIS (TM) BHI WITH HRBC, CHLORA/GENTAM/CYCLOHEXI 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 K874173. 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) BHI WITH HRBC, CHLORA/GENTAM/CYCLOHEXI?

BIOTIS (TM) BHI WITH HRBC, CHLORA/GENTAM/CYCLOHEXI 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 K874173.

When did BIOTIS (TM) BHI WITH HRBC, CHLORA/GENTAM/CYCLOHEXI receive FDA 510(k) clearance?

BIOTIS (TM) BHI WITH HRBC, CHLORA/GENTAM/CYCLOHEXI received FDA 510(k) clearance on 1987-10-28, under 510(k) number K874173.

Who is the listed applicant for BIOTIS (TM) BHI WITH HRBC, CHLORA/GENTAM/CYCLOHEXI?

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) BHI WITH HRBC, CHLORA/GENTAM/CYCLOHEXI?

The FDA product code for BIOTIS (TM) BHI WITH HRBC, CHLORA/GENTAM/CYCLOHEXI 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

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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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