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FDA 510(k)

CYTOMEGALOVIRUS ANTIBODY FLUORO-KIT II

K-Number: K833089 · 1984-05-02

ApplicantClinical Sciences, Inc.
Decision Date1984-05-02
Product CodeGQH
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CYTOMEGALOVIRUS ANTIBODY FLUORO-KIT II is the device name listed in this FDA 510(k) record. The listed applicant is Clinical Sciences, Inc.. It received FDA 510(k) clearance on 1984-05-02 under 510(k) number K833089. The device is classified under product code GQH. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CYTOMEGALOVIRUS ANTIBODY FLUORO-KIT II?

CYTOMEGALOVIRUS ANTIBODY FLUORO-KIT II is a medical device that received FDA 510(k) clearance on 1984-05-02. The listed applicant is Clinical Sciences, Inc.. The 510(k) number is K833089.

When did CYTOMEGALOVIRUS ANTIBODY FLUORO-KIT II receive FDA 510(k) clearance?

CYTOMEGALOVIRUS ANTIBODY FLUORO-KIT II received FDA 510(k) clearance on 1984-05-02, under 510(k) number K833089.

Who is the listed applicant for CYTOMEGALOVIRUS ANTIBODY FLUORO-KIT II?

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

What is the FDA product code for CYTOMEGALOVIRUS ANTIBODY FLUORO-KIT II?

The FDA product code for CYTOMEGALOVIRUS ANTIBODY FLUORO-KIT II is GQH.

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Related Devices (Code: GQH)

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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