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FDA 510(k)

VARICELLA-ZOSTER FA LABELED PRESERUM

K-Number: K770810 · 1977-05-20

ApplicantFlow Laboratories, Inc.
Decision Date1977-05-20
Product CodeGQX
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

VARICELLA-ZOSTER FA LABELED PRESERUM 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 1977-05-20 under 510(k) number K770810. The device is classified under product code GQX. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VARICELLA-ZOSTER FA LABELED PRESERUM?

VARICELLA-ZOSTER FA LABELED PRESERUM is a medical device that received FDA 510(k) clearance on 1977-05-20. The listed applicant is Flow Laboratories, Inc.. The 510(k) number is K770810.

When did VARICELLA-ZOSTER FA LABELED PRESERUM receive FDA 510(k) clearance?

VARICELLA-ZOSTER FA LABELED PRESERUM received FDA 510(k) clearance on 1977-05-20, under 510(k) number K770810.

Who is the listed applicant for VARICELLA-ZOSTER FA LABELED PRESERUM?

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 VARICELLA-ZOSTER FA LABELED PRESERUM?

The FDA product code for VARICELLA-ZOSTER FA LABELED PRESERUM is GQX.

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Other records listing Flow Laboratories, Inc. as applicant

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Related Devices (Code: GQX)

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.

K951799VARICELLA-ZOSTER VIRUS DIRECT IMMUNOFLUORESCENCE ASSAYLight DiagnosticsK911301VZV IGM TESTGull Laboratories, Inc.K883427VIRGO(R) VZV-IGG ELISAElectro-Nucleonics, Inc.K875358VZV TESTGull Laboratories, Inc.K863317ENZYGNOST ANTI-VZV IGG TESTBehring Diagnostics, Inc.K853540FIAX TEST KIT FOR VARICELLA ANTIBODY SEROLOGYIdt, A Division of Whittaker M.A. Bioproducts

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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