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FDA 510(k)

ROCHE DIAGNOSTICS COBAS ELECSYS ANTI-TPO

K-Number: K051890 · 2005-08-04

ApplicantRoche Diagnostics Corp.
Decision Date2005-08-04
Product CodeJZO
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ROCHE DIAGNOSTICS COBAS ELECSYS ANTI-TPO 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 2005-08-04 under 510(k) number K051890. 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 DIAGNOSTICS COBAS ELECSYS ANTI-TPO?

ROCHE DIAGNOSTICS COBAS ELECSYS ANTI-TPO is a medical device that received FDA 510(k) clearance on 2005-08-04. The listed applicant is Roche Diagnostics Corp.. The 510(k) number is K051890.

When did ROCHE DIAGNOSTICS COBAS ELECSYS ANTI-TPO receive FDA 510(k) clearance?

ROCHE DIAGNOSTICS COBAS ELECSYS ANTI-TPO received FDA 510(k) clearance on 2005-08-04, under 510(k) number K051890.

Who is the listed applicant for ROCHE DIAGNOSTICS COBAS ELECSYS ANTI-TPO?

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 DIAGNOSTICS COBAS ELECSYS ANTI-TPO?

The FDA product code for ROCHE DIAGNOSTICS COBAS ELECSYS ANTI-TPO 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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