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FDA 510(k)

ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTES

K-Number: K951595 · 1995-09-08

ApplicantRoche Diagnostic Systems, Inc.
Decision Date1995-09-08
Product CodeCGX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTES is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostic Systems, Inc.. It received FDA 510(k) clearance on 1995-09-08 under 510(k) number K951595. The device is classified under product code CGX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTES?

ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTES is a medical device that received FDA 510(k) clearance on 1995-09-08. The listed applicant is Roche Diagnostic Systems, Inc.. The 510(k) number is K951595.

When did ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTES receive FDA 510(k) clearance?

ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTES received FDA 510(k) clearance on 1995-09-08, under 510(k) number K951595.

Who is the listed applicant for ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTES?

The FDA 510(k) record lists Roche Diagnostic Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTES?

The FDA product code for ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTES is CGX.

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Related Devices (Code: CGX)

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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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