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FDA 510(k)

VARICELLA-ZOSTER FA LABELLED (8-321 RF)

K-Number: K770806 · 1977-05-20

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

Device Summary

VARICELLA-ZOSTER FA LABELLED (8-321 RF) 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 K770806. 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 LABELLED (8-321 RF)?

VARICELLA-ZOSTER FA LABELLED (8-321 RF) 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 K770806.

When did VARICELLA-ZOSTER FA LABELLED (8-321 RF) receive FDA 510(k) clearance?

VARICELLA-ZOSTER FA LABELLED (8-321 RF) received FDA 510(k) clearance on 1977-05-20, under 510(k) number K770806.

Who is the listed applicant for VARICELLA-ZOSTER FA LABELLED (8-321 RF)?

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 LABELLED (8-321 RF)?

The FDA product code for VARICELLA-ZOSTER FA LABELLED (8-321 RF) 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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