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FDA 510(k)

BARTELS HERPES SIMPLEX VIRUS 1 IGG EIA

K-Number: K922584 · 1992-09-18

ApplicantBaxter Diagnostics, Inc.
Decision Date1992-09-18
Product CodeLGC
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BARTELS HERPES SIMPLEX VIRUS 1 IGG EIA is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Diagnostics, Inc.. It received FDA 510(k) clearance on 1992-09-18 under 510(k) number K922584. 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 BARTELS HERPES SIMPLEX VIRUS 1 IGG EIA?

BARTELS HERPES SIMPLEX VIRUS 1 IGG EIA is a medical device that received FDA 510(k) clearance on 1992-09-18. The listed applicant is Baxter Diagnostics, Inc.. The 510(k) number is K922584.

When did BARTELS HERPES SIMPLEX VIRUS 1 IGG EIA receive FDA 510(k) clearance?

BARTELS HERPES SIMPLEX VIRUS 1 IGG EIA received FDA 510(k) clearance on 1992-09-18, under 510(k) number K922584.

Who is the listed applicant for BARTELS HERPES SIMPLEX VIRUS 1 IGG EIA?

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

What is the FDA product code for BARTELS HERPES SIMPLEX VIRUS 1 IGG EIA?

The FDA product code for BARTELS HERPES SIMPLEX VIRUS 1 IGG EIA is LGC.

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Other records listing Baxter 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.

K934458DRIED GRAM-POSITIVE MIC/COMBO PANELSK950817DRIED GRAM POSITIVE MIC/COMBO PANELS/PNEUMOCOCCIK935704DRIED GRAM-NEGATIVE MIC//COMBO PANELSK950570STRATUS PROGESTERONE FLUOROMETRIC ENZYME IMMUNOASSAYK945235DRIED GRAM-POSITIVE MIC/COMBO PANELSK941030DRIED GRAM-NEGATIVE CEFPODOXIME

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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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