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FDA 510(k)

HSV-1 AND/OR -2 IGM ELISA TEST SYSTEM

K-Number: K983656 · 1999-03-18

ApplicantZeus Scientific, Inc.
Decision Date1999-03-18
Product CodeLGC
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

HSV-1 AND/OR -2 IGM ELISA TEST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Zeus Scientific, Inc.. It received FDA 510(k) clearance on 1999-03-18 under 510(k) number K983656. 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 HSV-1 AND/OR -2 IGM ELISA TEST SYSTEM?

HSV-1 AND/OR -2 IGM ELISA TEST SYSTEM is a medical device that received FDA 510(k) clearance on 1999-03-18. The listed applicant is Zeus Scientific, Inc.. The 510(k) number is K983656.

When did HSV-1 AND/OR -2 IGM ELISA TEST SYSTEM receive FDA 510(k) clearance?

HSV-1 AND/OR -2 IGM ELISA TEST SYSTEM received FDA 510(k) clearance on 1999-03-18, under 510(k) number K983656.

Who is the listed applicant for HSV-1 AND/OR -2 IGM ELISA TEST SYSTEM?

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

What is the FDA product code for HSV-1 AND/OR -2 IGM ELISA TEST SYSTEM?

The FDA product code for HSV-1 AND/OR -2 IGM ELISA TEST SYSTEM is LGC.

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Other records listing Zeus Scientific, 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.

K201956Zeus IFA ANA HEp-2 Test System, Zeus dIFineK191240ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgM Test SystemK190907ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG/IgM Test SystemK191398ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG Test SystemK113397ZEUS ELISA BORRELIA VLSE-1/PEPC10 IGG/IGM TEST SYSTEMK102425ZEUS ELISA CARDIOLIPIN IGG/IGM/IGA TEST SYSTEM

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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

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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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