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FDA 510(k)

ROCHE DIAGNOSTICS OMNI S ANALYZER

K-Number: K032311 · 2003-10-17

ApplicantRoche Diagnostics Corp.
Decision Date2003-10-17
Product CodeCEM
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ROCHE DIAGNOSTICS OMNI S ANALYZER 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 2003-10-17 under 510(k) number K032311. The device is classified under product code CEM. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROCHE DIAGNOSTICS OMNI S ANALYZER?

ROCHE DIAGNOSTICS OMNI S ANALYZER is a medical device that received FDA 510(k) clearance on 2003-10-17. The listed applicant is Roche Diagnostics Corp.. The 510(k) number is K032311.

When did ROCHE DIAGNOSTICS OMNI S ANALYZER receive FDA 510(k) clearance?

ROCHE DIAGNOSTICS OMNI S ANALYZER received FDA 510(k) clearance on 2003-10-17, under 510(k) number K032311.

Who is the listed applicant for ROCHE DIAGNOSTICS OMNI S ANALYZER?

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 OMNI S ANALYZER?

The FDA product code for ROCHE DIAGNOSTICS OMNI S ANALYZER is CEM.

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Other records listing Roche Diagnostics Corp. as applicant

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Related Devices (Code: CEM)

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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