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FDA 510(k)

BIOTIS TSI

K-Number: K860413 · 1986-02-24

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

Device Summary

BIOTIS TSI 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 K860413. The device is classified under product code JSE. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOTIS TSI?

BIOTIS TSI 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 K860413.

When did BIOTIS TSI receive FDA 510(k) clearance?

BIOTIS TSI received FDA 510(k) clearance on 1986-02-24, under 510(k) number K860413.

Who is the listed applicant for BIOTIS TSI?

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 TSI?

The FDA product code for BIOTIS TSI is JSE.

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Other records listing Otisville Biotech, 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.

K862397BIOTIS DECARBOXYLASE MEDIA, LYSINEK862393BIOTIS LITMUS MILKK862398BIOTIS DECARBOXYLASE MEDIA, ORNITHINEK862390BIOTIS BORDET GENGOU AGARK862388BIOTIS TCBS AGARK862392BIOTIS MOTILITY TEST MEDIUM

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Related Devices (Code: JSE)

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.

K962265MLX MICROTITER PLATE LUMINOMETERDynatech Laboratories, Inc.K883995X-ACT UREA/TDAPro-Lab, Inc.K883996X-ACT LDC/INDPro-Lab, Inc.K880133MIL MEDIUMHardy MediaK880116MRVP BROTHHardy MediaK874537KLIGLER IRON AGAR AND TRIPLE SUGAR IRON AGARLakewood Biochemical Co., 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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