FDA 510(k)

BIOTIS TSB WITH 6.5% NACL

K-Number: K860405 · 1986-02-24

Decision Date1986-02-24

Product CodeJSJ

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

BIOTIS TSB WITH 6.5% NACL 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 K860405. 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 TSB WITH 6.5% NACL?

BIOTIS TSB WITH 6.5% NACL 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 K860405.

When did BIOTIS TSB WITH 6.5% NACL receive FDA 510(k) clearance?

BIOTIS TSB WITH 6.5% NACL received FDA 510(k) clearance on 1986-02-24, under 510(k) number K860405.

Who is the listed applicant for BIOTIS TSB WITH 6.5% NACL?

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 TSB WITH 6.5% NACL?

The FDA product code for BIOTIS TSB WITH 6.5% NACL is JSJ.

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Other records listing Otisville Biotech, Inc. as applicant

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Related Devices (Code: JSJ)

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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.