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FDA 510(k)

BION BORRELIA BURGDORFERI ANTIGEN SUBSTRATE SLIDE

K-Number: K901054 · 1990-04-05

ApplicantBion Ent., Ltd.
Decision Date1990-04-05
Product CodeLSR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BION BORRELIA BURGDORFERI ANTIGEN SUBSTRATE SLIDE is the device name listed in this FDA 510(k) record. The listed applicant is Bion Ent., Ltd.. It received FDA 510(k) clearance on 1990-04-05 under 510(k) number K901054. The device is classified under product code LSR. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BION BORRELIA BURGDORFERI ANTIGEN SUBSTRATE SLIDE?

BION BORRELIA BURGDORFERI ANTIGEN SUBSTRATE SLIDE is a medical device that received FDA 510(k) clearance on 1990-04-05. The listed applicant is Bion Ent., Ltd.. The 510(k) number is K901054.

When did BION BORRELIA BURGDORFERI ANTIGEN SUBSTRATE SLIDE receive FDA 510(k) clearance?

BION BORRELIA BURGDORFERI ANTIGEN SUBSTRATE SLIDE received FDA 510(k) clearance on 1990-04-05, under 510(k) number K901054.

Who is the listed applicant for BION BORRELIA BURGDORFERI ANTIGEN SUBSTRATE SLIDE?

The FDA 510(k) record lists Bion Ent., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BION BORRELIA BURGDORFERI ANTIGEN SUBSTRATE SLIDE?

The FDA product code for BION BORRELIA BURGDORFERI ANTIGEN SUBSTRATE SLIDE is LSR.

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Other records listing Bion Ent., Ltd. as applicant

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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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