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FDA 510(k)

Elecsys HSV-1 IgG (08948844160)

K-Number: K220923 · 2022-10-12

ApplicantRoche Diagnostics
Decision Date2022-10-12
Product CodeMXJ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Elecsys HSV-1 IgG (08948844160) is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics. It received FDA 510(k) clearance on 2022-10-12 under 510(k) number K220923. 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 (08948844160)?

Elecsys HSV-1 IgG (08948844160) is a medical device that received FDA 510(k) clearance on 2022-10-12. The listed applicant is Roche Diagnostics. The 510(k) number is K220923.

When did Elecsys HSV-1 IgG (08948844160) receive FDA 510(k) clearance?

Elecsys HSV-1 IgG (08948844160) received FDA 510(k) clearance on 2022-10-12, under 510(k) number K220923.

Who is the listed applicant for Elecsys HSV-1 IgG (08948844160)?

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 (08948844160)?

The FDA product code for Elecsys HSV-1 IgG (08948844160) is MXJ.

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.

K252323cobas pulse blood glucose monitoring systemPMA P990056Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancerPMA P000027PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERSK252431Elecsys CalcitoninK252280Elecsys Anti-SARS-CoV-2 SK260049Elecsys Anti-HBc IgM

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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.K181333ADVIA Centaur Herpes-1 IgGBiokit, S.A.K162276SeraQuest Herpes Type 1 Specific IgGQuest International, 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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