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FDA 510(k)

BIOTIS COOKED MEAT

K-Number: K860410 · 1986-02-24

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

Device Summary

BIOTIS COOKED MEAT 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 K860410. The device is classified under product code KZI. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOTIS COOKED MEAT?

BIOTIS COOKED MEAT 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 K860410.

When did BIOTIS COOKED MEAT receive FDA 510(k) clearance?

BIOTIS COOKED MEAT received FDA 510(k) clearance on 1986-02-24, under 510(k) number K860410.

Who is the listed applicant for BIOTIS COOKED MEAT?

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 COOKED MEAT?

The FDA product code for BIOTIS COOKED MEAT is KZI.

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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: KZI)

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.

K884208LISTERIA SELECTIVE MEDIUM (OXFORD FORMULATION)Oxoid U.S.A., Inc.K881995DIAMOND'S MEDIUM MODIFIEDRemel Co.K880122MIDDLEBROOK 7H9 BROTHHardy MediaK880131LOWENSTEIN-JENSEN, GRUFTHardy MediaK880134MIDDLEBROOK 7H11 AGARHardy MediaK880138WALLENSTEIN MEDIUM SLANTHardy 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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