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FDA 510(k)

ELECSYS HSV-2 IGG IMMUNOASSAY

K-Number: K121895 · 2012-08-24

ApplicantRoche Diagnostics
Decision Date2012-08-24
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ELECSYS HSV-2 IGG IMMUNOASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics. It received FDA 510(k) clearance on 2012-08-24 under 510(k) number K121895. The device is classified under product code JJX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELECSYS HSV-2 IGG IMMUNOASSAY?

ELECSYS HSV-2 IGG IMMUNOASSAY is a medical device that received FDA 510(k) clearance on 2012-08-24. The listed applicant is Roche Diagnostics. The 510(k) number is K121895.

When did ELECSYS HSV-2 IGG IMMUNOASSAY receive FDA 510(k) clearance?

ELECSYS HSV-2 IGG IMMUNOASSAY received FDA 510(k) clearance on 2012-08-24, under 510(k) number K121895.

Who is the listed applicant for ELECSYS HSV-2 IGG IMMUNOASSAY?

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-2 IGG IMMUNOASSAY?

The FDA product code for ELECSYS HSV-2 IGG IMMUNOASSAY is JJX.

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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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