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FDA 510(k)

BIOTIS HAEMOPHILUS IDENTIFICATION QUAD

K-Number: K862387 · 1986-07-03

ApplicantOtisville Biotech, Inc.
Decision Date1986-07-03
Product CodeJSH
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BIOTIS HAEMOPHILUS IDENTIFICATION QUAD 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 1986-07-03 under 510(k) number K862387. The device is classified under product code JSH. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOTIS HAEMOPHILUS IDENTIFICATION QUAD?

BIOTIS HAEMOPHILUS IDENTIFICATION QUAD is a medical device that received FDA 510(k) clearance on 1986-07-03. The listed applicant is Otisville Biotech, Inc.. The 510(k) number is K862387.

When did BIOTIS HAEMOPHILUS IDENTIFICATION QUAD receive FDA 510(k) clearance?

BIOTIS HAEMOPHILUS IDENTIFICATION QUAD received FDA 510(k) clearance on 1986-07-03, under 510(k) number K862387.

Who is the listed applicant for BIOTIS HAEMOPHILUS IDENTIFICATION QUAD?

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 HAEMOPHILUS IDENTIFICATION QUAD?

The FDA product code for BIOTIS HAEMOPHILUS IDENTIFICATION QUAD is JSH.

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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: JSH)

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.

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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.

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