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FDA 510(k)

COLORGENE FLUORESCENT DNA HYBRIDIZATION TEST / CMV

K-Number: K875367 · 1988-03-28

ApplicantEnzo Biochem, Inc.
Decision Date1988-03-28
Product CodeGQM
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

COLORGENE FLUORESCENT DNA HYBRIDIZATION TEST / CMV 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 1988-03-28 under 510(k) number K875367. The device is classified under product code GQM. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COLORGENE FLUORESCENT DNA HYBRIDIZATION TEST / CMV?

COLORGENE FLUORESCENT DNA HYBRIDIZATION TEST / CMV is a medical device that received FDA 510(k) clearance on 1988-03-28. The listed applicant is Enzo Biochem, Inc.. The 510(k) number is K875367.

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

COLORGENE FLUORESCENT DNA HYBRIDIZATION TEST / CMV received FDA 510(k) clearance on 1988-03-28, under 510(k) number K875367.

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

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 FLUORESCENT DNA HYBRIDIZATION TEST / CMV?

The FDA product code for COLORGENE FLUORESCENT DNA HYBRIDIZATION TEST / CMV is GQM.

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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 BLOODK872576COLORGENE DNA HYBRIDIZATION TEST CMV CONFIRMATIONK870733COLORGENE DNA HYBRIDIZATION TEST FOR HSV CONFIRMA.

Related Devices (Code: GQM)

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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