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FDA 510(k)

COLORGENE DNA HYBRIDIZATION TEST FOR HSV CONFIRMA.

K-Number: K870733 · 1987-05-26

ApplicantEnzo Biochem, Inc.
Decision Date1987-05-26
Product CodeGQN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

COLORGENE DNA HYBRIDIZATION TEST FOR HSV CONFIRMA. 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 1987-05-26 under 510(k) number K870733. 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 DNA HYBRIDIZATION TEST FOR HSV CONFIRMA.?

COLORGENE DNA HYBRIDIZATION TEST FOR HSV CONFIRMA. is a medical device that received FDA 510(k) clearance on 1987-05-26. The listed applicant is Enzo Biochem, Inc.. The 510(k) number is K870733.

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

COLORGENE DNA HYBRIDIZATION TEST FOR HSV CONFIRMA. received FDA 510(k) clearance on 1987-05-26, under 510(k) number K870733.

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

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 FOR HSV CONFIRMA.?

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

Related Clinical Trials

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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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 / CMVK872576COLORGENE DNA HYBRIDIZATION TEST CMV CONFIRMATION

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.K964874HSV-1 ANTIGEN CONTROL SLIDESViral Antigens, Inc.K971101HSV-2 ANTIGEN CONTROL SLIDESViral Antigens, 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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