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FDA 510(k)

COLORGENE HSV DNA HYBRIDIZATION TEST

K-Number: K880604 · 1988-08-03

ApplicantEnzo Biochem, Inc.
Decision Date1988-08-03
Product CodeGQN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

COLORGENE HSV DNA HYBRIDIZATION TEST 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 1988-08-03 under 510(k) number K880604. The device is classified under product code GQN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COLORGENE HSV DNA HYBRIDIZATION TEST?

COLORGENE HSV DNA HYBRIDIZATION TEST is a medical device that received FDA 510(k) clearance on 1988-08-03. The listed applicant is Enzo Biochem, Inc.. The 510(k) number is K880604.

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

COLORGENE HSV DNA HYBRIDIZATION TEST received FDA 510(k) clearance on 1988-08-03, under 510(k) number K880604.

Who is the listed applicant for COLORGENE HSV DNA HYBRIDIZATION TEST?

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 HSV DNA HYBRIDIZATION TEST?

The FDA product code for COLORGENE HSV DNA HYBRIDIZATION TEST is GQN.

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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.

K881907HEMAGEL(TM) TEST FOR FECAL OCCULT BLOODK875367COLORGENE FLUORESCENT DNA HYBRIDIZATION TEST / CMVK872576COLORGENE DNA HYBRIDIZATION TEST CMV CONFIRMATIONK870733COLORGENE DNA HYBRIDIZATION TEST FOR HSV CONFIRMA.

Related Devices (Code: GQN)

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.

K070265DIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPLEX VIRUS IDENTIFICATION AND TYPING KIT, MODEL 01-090000Diagnostic Hybrids, Inc.K063798DIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPLEX VIRUS IDENTIFICATION KIT, MODEL 01-080000Diagnostic Hybrids, Inc.K991880LIGHT DIAGNOSTICS SIMULFLUOR HSV 1/2 IMMUNOFLUORECENCE ASSAYLight DiagnosticsK971662ELVIS HSV ID/TYPING TEST SYSTEMDiagnostic Hybrids, Inc.K971101HSV-2 ANTIGEN CONTROL SLIDESViral Antigens, Inc.K964874HSV-1 ANTIGEN CONTROL SLIDESViral Antigens, 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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