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FDA 510(k)

BIOTIS (TM) MUELLER HINTON W/4% SALT, 6MCG/ML OXAC

K-Number: K874175 · 1987-12-04

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

Device Summary

BIOTIS (TM) MUELLER HINTON W/4% SALT, 6MCG/ML OXAC 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 K874175. The device is classified under product code JSF. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOTIS (TM) MUELLER HINTON W/4% SALT, 6MCG/ML OXAC?

BIOTIS (TM) MUELLER HINTON W/4% SALT, 6MCG/ML OXAC 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 K874175.

When did BIOTIS (TM) MUELLER HINTON W/4% SALT, 6MCG/ML OXAC receive FDA 510(k) clearance?

BIOTIS (TM) MUELLER HINTON W/4% SALT, 6MCG/ML OXAC received FDA 510(k) clearance on 1987-12-04, under 510(k) number K874175.

Who is the listed applicant for BIOTIS (TM) MUELLER HINTON W/4% SALT, 6MCG/ML OXAC?

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) MUELLER HINTON W/4% SALT, 6MCG/ML OXAC?

The FDA product code for BIOTIS (TM) MUELLER HINTON W/4% SALT, 6MCG/ML OXAC is JSF.

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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 BCPK874178BIOTIS (TM) BCYE SELECTIVEK874177BIOTIS (TM) BCYEK874173BIOTIS (TM) BHI WITH HRBC, CHLORA/GENTAM/CYCLOHEXI

View all 8 devices →

Related Devices (Code: JSF)

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.

K880946NUTRIENT GELATIN - PRODUCT NUMBER T2860Lakewood Biochemical Co., Inc.K880126LAURYL TRYPTOSE BROTHHardy MediaK880119MOELLERS DECARBOXYLASE, ONITHINEHardy MediaK880120MOELLERS DECARBOXYLASE, LYSINEHardy MediaK880139ONPG TEST REAGENTHardy MediaK880113CYSTINE TRYPTIC MEDIUM W/LACTOSEHardy Media

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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