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FDA 510(k)

BIOTIS LYSINE IRON AGAR

K-Number: K843770 · 1984-10-10

ApplicantOtisville Biotech, Inc.
Decision Date1984-10-10
Product Code
DecisionSubstantially Equivalent

Device Summary

BIOTIS LYSINE IRON 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 K843770. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOTIS LYSINE IRON AGAR?

BIOTIS LYSINE IRON 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 K843770.

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

BIOTIS LYSINE IRON AGAR received FDA 510(k) clearance on 1984-10-10, under 510(k) number K843770.

Who is the listed applicant for BIOTIS LYSINE IRON AGAR?

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

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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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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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