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FDA 510(k)

VISUWELL REAGIN II

K-Number: K952802 · 1996-05-23

ApplicantBiomira Diagnostics, Inc.
Decision Date1996-05-23
Product CodeGMQ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

VISUWELL REAGIN II is the device name listed in this FDA 510(k) record. The listed applicant is Biomira Diagnostics, Inc.. It received FDA 510(k) clearance on 1996-05-23 under 510(k) number K952802. The device is classified under product code GMQ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VISUWELL REAGIN II?

VISUWELL REAGIN II is a medical device that received FDA 510(k) clearance on 1996-05-23. The listed applicant is Biomira Diagnostics, Inc.. The 510(k) number is K952802.

When did VISUWELL REAGIN II receive FDA 510(k) clearance?

VISUWELL REAGIN II received FDA 510(k) clearance on 1996-05-23, under 510(k) number K952802.

Who is the listed applicant for VISUWELL REAGIN II?

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

What is the FDA product code for VISUWELL REAGIN II?

The FDA product code for VISUWELL REAGIN II is GMQ.

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Other records listing Biomira Diagnostics, 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.

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Official Source

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