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FDA 510(k)

PREMIER TYPE SPECIFIC HSV-2 IGG ELISA TEST

K-Number: K984346 · 1999-06-25

ApplicantMeridian Diagnostics, Inc.
Decision Date1999-06-25
Product CodeLGC
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

PREMIER TYPE SPECIFIC HSV-2 IGG ELISA TEST is the device name listed in this FDA 510(k) record. The listed applicant is Meridian Diagnostics, Inc.. It received FDA 510(k) clearance on 1999-06-25 under 510(k) number K984346. 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 PREMIER TYPE SPECIFIC HSV-2 IGG ELISA TEST?

PREMIER TYPE SPECIFIC HSV-2 IGG ELISA TEST is a medical device that received FDA 510(k) clearance on 1999-06-25. The listed applicant is Meridian Diagnostics, Inc.. The 510(k) number is K984346.

When did PREMIER TYPE SPECIFIC HSV-2 IGG ELISA TEST receive FDA 510(k) clearance?

PREMIER TYPE SPECIFIC HSV-2 IGG ELISA TEST received FDA 510(k) clearance on 1999-06-25, under 510(k) number K984346.

Who is the listed applicant for PREMIER TYPE SPECIFIC HSV-2 IGG ELISA TEST?

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

What is the FDA product code for PREMIER TYPE SPECIFIC HSV-2 IGG ELISA TEST?

The FDA product code for PREMIER TYPE SPECIFIC HSV-2 IGG ELISA TEST is LGC.

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Other records listing Meridian 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.

K993914PREMIER TOXINS A&B, MODEL 616096K990263IMMUNOCARD STAT! E. COLI O157:H7K984343PREMIER TYPE SPECIFIC HSV-1 IGG ELISA TESTK983255MODIFICATION TO: PREMIER PLATINUM HPSAK982764PREMIER CRYPTOSPORIDIUMK982711PREMIER GIARDIA

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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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