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FDA 510(k)

ROCHE CHLORIDE ELECTRODE

K-Number: K890528 · 1989-03-31

ApplicantRoche Diagnostic Systems, Inc.
Decision Date1989-03-31
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ROCHE CHLORIDE ELECTRODE 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 1989-03-31 under 510(k) number K890528. The device is classified under product code CGA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROCHE CHLORIDE ELECTRODE?

ROCHE CHLORIDE ELECTRODE is a medical device that received FDA 510(k) clearance on 1989-03-31. The listed applicant is Roche Diagnostic Systems, Inc.. The 510(k) number is K890528.

When did ROCHE CHLORIDE ELECTRODE receive FDA 510(k) clearance?

ROCHE CHLORIDE ELECTRODE received FDA 510(k) clearance on 1989-03-31, under 510(k) number K890528.

Who is the listed applicant for ROCHE CHLORIDE ELECTRODE?

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 CHLORIDE ELECTRODE?

The FDA product code for ROCHE CHLORIDE ELECTRODE is CGA.

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Other records listing Roche Diagnostic Systems, Inc. as applicant

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Related Devices (Code: CGA)

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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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