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FDA 510(k)

COLORGENE DNA HYBRIDIZATION TEST CMV CONFIRMATION

K-Number: K872576 · 1987-12-04

ApplicantEnzo Biochem, Inc.
Decision Date1987-12-04
Product CodeGQH
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

COLORGENE DNA HYBRIDIZATION TEST CMV CONFIRMATION is the device name listed in this FDA 510(k) record. The listed applicant is Enzo Biochem, Inc.. It received FDA 510(k) clearance on 1987-12-04 under 510(k) number K872576. 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 COLORGENE DNA HYBRIDIZATION TEST CMV CONFIRMATION?

COLORGENE DNA HYBRIDIZATION TEST CMV CONFIRMATION is a medical device that received FDA 510(k) clearance on 1987-12-04. The listed applicant is Enzo Biochem, Inc.. The 510(k) number is K872576.

When did COLORGENE DNA HYBRIDIZATION TEST CMV CONFIRMATION receive FDA 510(k) clearance?

COLORGENE DNA HYBRIDIZATION TEST CMV CONFIRMATION received FDA 510(k) clearance on 1987-12-04, under 510(k) number K872576.

Who is the listed applicant for COLORGENE DNA HYBRIDIZATION TEST CMV CONFIRMATION?

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

What is the FDA product code for COLORGENE DNA HYBRIDIZATION TEST CMV CONFIRMATION?

The FDA product code for COLORGENE DNA HYBRIDIZATION TEST CMV CONFIRMATION is GQH.

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Other records listing Enzo Biochem, Inc. as applicant

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.

K880604COLORGENE HSV DNA HYBRIDIZATION TESTK881907HEMAGEL(TM) TEST FOR FECAL OCCULT BLOODK875367COLORGENE FLUORESCENT DNA HYBRIDIZATION TEST / CMVK870733COLORGENE DNA HYBRIDIZATION TEST FOR HSV CONFIRMA.

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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