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FDA 510(k)

COBAS INTEGRA CREATININE PLUS VER.2 ASSAY

K-Number: K024098 · 2002-12-19

ApplicantRoche Diagnostics Corp.
Decision Date2002-12-19
Product CodeJFY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

COBAS INTEGRA CREATININE PLUS VER.2 ASSAY 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 2002-12-19 under 510(k) number K024098. The device is classified under product code JFY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COBAS INTEGRA CREATININE PLUS VER.2 ASSAY?

COBAS INTEGRA CREATININE PLUS VER.2 ASSAY is a medical device that received FDA 510(k) clearance on 2002-12-19. The listed applicant is Roche Diagnostics Corp.. The 510(k) number is K024098.

When did COBAS INTEGRA CREATININE PLUS VER.2 ASSAY receive FDA 510(k) clearance?

COBAS INTEGRA CREATININE PLUS VER.2 ASSAY received FDA 510(k) clearance on 2002-12-19, under 510(k) number K024098.

Who is the listed applicant for COBAS INTEGRA CREATININE PLUS VER.2 ASSAY?

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 COBAS INTEGRA CREATININE PLUS VER.2 ASSAY?

The FDA product code for COBAS INTEGRA CREATININE PLUS VER.2 ASSAY is JFY.

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Other records listing Roche Diagnostics Corp. as applicant

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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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