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FDA 510(k)

ROCHE ELECSYS ANTI-TG

K-Number: K053426 · 2006-02-07

ApplicantRoche Diagnostics Corp.
Decision Date2006-02-07
Product CodeJZO
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ROCHE ELECSYS ANTI-TG is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics Corp.. It received FDA 510(k) clearance on 2006-02-07 under 510(k) number K053426. The device is classified under product code JZO. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROCHE ELECSYS ANTI-TG?

ROCHE ELECSYS ANTI-TG is a medical device that received FDA 510(k) clearance on 2006-02-07. The listed applicant is Roche Diagnostics Corp.. The 510(k) number is K053426.

When did ROCHE ELECSYS ANTI-TG receive FDA 510(k) clearance?

ROCHE ELECSYS ANTI-TG received FDA 510(k) clearance on 2006-02-07, under 510(k) number K053426.

Who is the listed applicant for ROCHE ELECSYS ANTI-TG?

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

What is the FDA product code for ROCHE ELECSYS ANTI-TG?

The FDA product code for ROCHE ELECSYS ANTI-TG is JZO.

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Related Devices (Code: JZO)

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.

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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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