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FDA 510(k)

VIRAL ANTISERA, FLUORESCEIN LABELED

K-Number: K770216 · 1977-03-01

ApplicantFlow Laboratories, Inc.
Decision Date1977-03-01
Product CodeGRA
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

VIRAL ANTISERA, FLUORESCEIN LABELED is the device name listed in this FDA 510(k) record. The listed applicant is Flow Laboratories, Inc.. It received FDA 510(k) clearance on 1977-03-01 under 510(k) number K770216. The device is classified under product code GRA. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VIRAL ANTISERA, FLUORESCEIN LABELED?

VIRAL ANTISERA, FLUORESCEIN LABELED is a medical device that received FDA 510(k) clearance on 1977-03-01. The listed applicant is Flow Laboratories, Inc.. The 510(k) number is K770216.

When did VIRAL ANTISERA, FLUORESCEIN LABELED receive FDA 510(k) clearance?

VIRAL ANTISERA, FLUORESCEIN LABELED received FDA 510(k) clearance on 1977-03-01, under 510(k) number K770216.

Who is the listed applicant for VIRAL ANTISERA, FLUORESCEIN LABELED?

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

What is the FDA product code for VIRAL ANTISERA, FLUORESCEIN LABELED?

The FDA product code for VIRAL ANTISERA, FLUORESCEIN LABELED is GRA.

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Related Devices (Code: GRA)

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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