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FDA 510(k)

CYTOMEGALO VIRUS & CONTROLS

K-Number: K802930 · 1981-01-09

ApplicantOrion Diagnostica, Inc.
Decision Date1981-01-09
Product CodeGQH
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CYTOMEGALO VIRUS & CONTROLS is the device name listed in this FDA 510(k) record. The listed applicant is Orion Diagnostica, Inc.. It received FDA 510(k) clearance on 1981-01-09 under 510(k) number K802930. 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 CYTOMEGALO VIRUS & CONTROLS?

CYTOMEGALO VIRUS & CONTROLS is a medical device that received FDA 510(k) clearance on 1981-01-09. The listed applicant is Orion Diagnostica, Inc.. The 510(k) number is K802930.

When did CYTOMEGALO VIRUS & CONTROLS receive FDA 510(k) clearance?

CYTOMEGALO VIRUS & CONTROLS received FDA 510(k) clearance on 1981-01-09, under 510(k) number K802930.

Who is the listed applicant for CYTOMEGALO VIRUS & CONTROLS?

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

What is the FDA product code for CYTOMEGALO VIRUS & CONTROLS?

The FDA product code for CYTOMEGALO VIRUS & CONTROLS is GQH.

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Other records listing Orion Diagnostica, Inc. as applicant

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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.

K982311BARTELS CINAKIT CMV ANTIGENEMIAIntracel Corp.K964875CMV ANTIGEN CONTROL SLIDESViral Antigens, Inc.K935809CYTOMEGALOVIRUS INDIRECT IMMUNOFLUORESCENCE ASSAYLight DiagnosticsK882835INDIRECT FLUORESCENT ASSAY FOR (HCMV)Stellar Bio Systems, Inc.K882024FITC MURINE MONOCLONAL ANTI-CMV IGGWhittaker Bioproducts, Inc.K881932ORTHO* CYTOMEGALOVIRUS IDENTIFICATION REAGENTOrtho Diagnostic Systems, Inc.

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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