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FDA 510(k)

BIOTIS MYCOBIOTIC AGAR

K-Number: K843765 · 1984-10-10

ApplicantOtisville Biotech, Inc.
Decision Date1984-10-10
Product CodeJSJ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BIOTIS MYCOBIOTIC AGAR 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 1984-10-10 under 510(k) number K843765. 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 MYCOBIOTIC AGAR?

BIOTIS MYCOBIOTIC AGAR is a medical device that received FDA 510(k) clearance on 1984-10-10. The listed applicant is Otisville Biotech, Inc.. The 510(k) number is K843765.

When did BIOTIS MYCOBIOTIC AGAR receive FDA 510(k) clearance?

BIOTIS MYCOBIOTIC AGAR received FDA 510(k) clearance on 1984-10-10, under 510(k) number K843765.

Who is the listed applicant for BIOTIS MYCOBIOTIC AGAR?

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 MYCOBIOTIC AGAR?

The FDA product code for BIOTIS MYCOBIOTIC AGAR is JSJ.

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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: 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.

K882463POTATO DEXTROSE AGAR (PDA) - PRODUCT #P3421Lakewood Biochemical Co., Inc.K881544LITTMAN AGARAcumedia Manufacturers, Inc.K881561TERGITOL 7 BROTHAcumedia Manufacturers, Inc.K881526CHAPMAN STONE MEDIUMAcumedia Manufacturers, Inc.K881571YM BROTHAcumedia Manufacturers, Inc.K881578STREPTOSELAcumedia Manufacturers, 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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