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FDA 510(k)

IMMUNODIAGNOSTIC ASSAY SYSTEM HERPES SIMPLEX VIRUS

K-Number: K910499 · 1991-05-01

ApplicantVitek Systems, Inc.
Decision Date1991-05-01
Product CodeLGC
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

IMMUNODIAGNOSTIC ASSAY SYSTEM HERPES SIMPLEX VIRUS is the device name listed in this FDA 510(k) record. The listed applicant is Vitek Systems, Inc.. It received FDA 510(k) clearance on 1991-05-01 under 510(k) number K910499. The device is classified under product code LGC. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMMUNODIAGNOSTIC ASSAY SYSTEM HERPES SIMPLEX VIRUS?

IMMUNODIAGNOSTIC ASSAY SYSTEM HERPES SIMPLEX VIRUS is a medical device that received FDA 510(k) clearance on 1991-05-01. The listed applicant is Vitek Systems, Inc.. The 510(k) number is K910499.

When did IMMUNODIAGNOSTIC ASSAY SYSTEM HERPES SIMPLEX VIRUS receive FDA 510(k) clearance?

IMMUNODIAGNOSTIC ASSAY SYSTEM HERPES SIMPLEX VIRUS received FDA 510(k) clearance on 1991-05-01, under 510(k) number K910499.

Who is the listed applicant for IMMUNODIAGNOSTIC ASSAY SYSTEM HERPES SIMPLEX VIRUS?

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

What is the FDA product code for IMMUNODIAGNOSTIC ASSAY SYSTEM HERPES SIMPLEX VIRUS?

The FDA product code for IMMUNODIAGNOSTIC ASSAY SYSTEM HERPES SIMPLEX VIRUS is LGC.

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Other records listing Vitek Systems, 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.

K920661VIDAS CMV IGG ASSAYK921302VITEK IMMUNODIAGNOSTIC ASSAY SYSTEMK921176VITEK IMMUNODIAGNOSTIC ASSAY SYSTEMK920952VITEK IMMUNODIAG ASSAY SYST(VIDAS) FERRITINE ASSAYK915884VIDAS CHLAMYDIA ASSAY, MODIFICATIONK905211VIDAS CLOSTRIDIUM DIFFICILE TOXIN A (CDA) ASSAY

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Related Devices (Code: LGC)

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.

K033059HERPES GROUP IGGTrinity Biotech, Inc.K010878MODIFICATION TO IMMULITE HERPES I & II IGG, MODEL L2KHS2 & L2KHS6Diagnostic Products Corp.K002262DIAMEDIX IS-HSV 1&2 IGM TEST SYSTEMDiamedix Corp.K000238HSV-1 & HSV-2 DIFFERENTIATION IMMUNOBLOT IGG, MODEL IB0900GMrl DiagnosticsK992166THE APTUS (AUTOMATED) APPLICATION OF THE HSV 1/2 IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FORZeus Scientific, Inc.K983886POCKIT HSV 2 RAPID TESTDiagnology , Ltd.

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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