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FDA 510(k)

IMAGEN HERPES SIMPLEX VIRUS (HSV) TYPING TEST

K-Number: K870602 · 1987-05-08

ApplicantBoots-Celltech Diagnostics, Inc.
Decision Date1987-05-08
Product CodeGQN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

IMAGEN HERPES SIMPLEX VIRUS (HSV) TYPING TEST is the device name listed in this FDA 510(k) record. The listed applicant is Boots-Celltech Diagnostics, Inc.. It received FDA 510(k) clearance on 1987-05-08 under 510(k) number K870602. 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 IMAGEN HERPES SIMPLEX VIRUS (HSV) TYPING TEST?

IMAGEN HERPES SIMPLEX VIRUS (HSV) TYPING TEST is a medical device that received FDA 510(k) clearance on 1987-05-08. The listed applicant is Boots-Celltech Diagnostics, Inc.. The 510(k) number is K870602.

When did IMAGEN HERPES SIMPLEX VIRUS (HSV) TYPING TEST receive FDA 510(k) clearance?

IMAGEN HERPES SIMPLEX VIRUS (HSV) TYPING TEST received FDA 510(k) clearance on 1987-05-08, under 510(k) number K870602.

Who is the listed applicant for IMAGEN HERPES SIMPLEX VIRUS (HSV) TYPING TEST?

The FDA 510(k) record lists Boots-Celltech Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IMAGEN HERPES SIMPLEX VIRUS (HSV) TYPING TEST?

The FDA product code for IMAGEN HERPES SIMPLEX VIRUS (HSV) TYPING TEST is GQN.

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Other records listing Boots-Celltech Diagnostics, 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.

K871877IDEIA HERPES SIMPLEX VIRUS TESTK880799MODIFIED IDEIA CHLAMYDIA TESTK880758SUCROSEP SPECIFIC IMMUNORADIOMETRIC ASSAYK874875CHEMELIA FREE THYROXINE(FT4)/ENZYME IMMUNO. (EIA)K872958IMAGEN INFLUENZA VIRUS A AND B TESTMIK872843OVEIA (TM) DUAL ANALYTE

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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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