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FDA 510(k)

BIOTIS SABHI WITH CHLORAMPHENICAL AND GENTAMYCIN

K-Number: K860390 · 1986-02-24

ApplicantOtisville Biotech, Inc.
Decision Date1986-02-24
Product CodeJSJ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BIOTIS SABHI WITH CHLORAMPHENICAL AND GENTAMYCIN is the device name listed in this FDA 510(k) record. The listed applicant is Otisville Biotech, Inc.. It received FDA 510(k) clearance on 1986-02-24 under 510(k) number K860390. 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 SABHI WITH CHLORAMPHENICAL AND GENTAMYCIN?

BIOTIS SABHI WITH CHLORAMPHENICAL AND GENTAMYCIN is a medical device that received FDA 510(k) clearance on 1986-02-24. The listed applicant is Otisville Biotech, Inc.. The 510(k) number is K860390.

When did BIOTIS SABHI WITH CHLORAMPHENICAL AND GENTAMYCIN receive FDA 510(k) clearance?

BIOTIS SABHI WITH CHLORAMPHENICAL AND GENTAMYCIN received FDA 510(k) clearance on 1986-02-24, under 510(k) number K860390.

Who is the listed applicant for BIOTIS SABHI WITH CHLORAMPHENICAL AND GENTAMYCIN?

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

What is the FDA product code for BIOTIS SABHI WITH CHLORAMPHENICAL AND GENTAMYCIN?

The FDA product code for BIOTIS SABHI WITH CHLORAMPHENICAL AND GENTAMYCIN is JSJ.

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Other records listing Otisville Biotech, Inc. as applicant

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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.

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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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