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FDA 510(k)

ELECSYS HSV-1 IGG IMMUNOASSAY ELECSYS PRECICONTROL HSV

K-Number: K120625 · 2012-07-25

ApplicantRoche Diagnostics
Decision Date2012-07-25
Product CodeMXJ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ELECSYS HSV-1 IGG IMMUNOASSAY ELECSYS PRECICONTROL HSV is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics. It received FDA 510(k) clearance on 2012-07-25 under 510(k) number K120625. The device is classified under product code MXJ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELECSYS HSV-1 IGG IMMUNOASSAY ELECSYS PRECICONTROL HSV?

ELECSYS HSV-1 IGG IMMUNOASSAY ELECSYS PRECICONTROL HSV is a medical device that received FDA 510(k) clearance on 2012-07-25. The listed applicant is Roche Diagnostics. The 510(k) number is K120625.

When did ELECSYS HSV-1 IGG IMMUNOASSAY ELECSYS PRECICONTROL HSV receive FDA 510(k) clearance?

ELECSYS HSV-1 IGG IMMUNOASSAY ELECSYS PRECICONTROL HSV received FDA 510(k) clearance on 2012-07-25, under 510(k) number K120625.

Who is the listed applicant for ELECSYS HSV-1 IGG IMMUNOASSAY ELECSYS PRECICONTROL HSV?

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

What is the FDA product code for ELECSYS HSV-1 IGG IMMUNOASSAY ELECSYS PRECICONTROL HSV?

The FDA product code for ELECSYS HSV-1 IGG IMMUNOASSAY ELECSYS PRECICONTROL HSV is MXJ.

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Other records listing Roche Diagnostics 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.

K261686Elecsys Phospho-Tau (217P) PlasmaK252323cobas pulse blood glucose monitoring systemK252280Elecsys Anti-SARS-CoV-2 SK260048Elecsys Anti-HAV IgMK260049Elecsys Anti-HBc IgMK260046Elecsys Anti-HBc II

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Related Devices (Code: MXJ)

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.

K213987ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG ControlsBiokit, S.A.K220923Elecsys HSV-1 IgG (08948844160)Roche DiagnosticsK181333ADVIA Centaur Herpes-1 IgGBiokit, S.A.K162276SeraQuest Herpes Type 1 Specific IgGQuest International, Inc.K120959BIOPLEX 2200 HSV-1 AND HSV-2 IGG KITBio-Rad LaboratoriesK103363ZEUS ELISA HSV GC-I IGG TEST SYSTEMZeus Scientific, 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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