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FDA 510(k)

ION-SPECIFIC ELECTRODE OPTION FOR COBAS FARA

K-Number: K852473 · 1985-07-12

ApplicantRoche Diagnostic Systems, Inc.
Decision Date1985-07-12
Product CodeJGS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ION-SPECIFIC ELECTRODE OPTION FOR COBAS FARA 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 1985-07-12 under 510(k) number K852473. The device is classified under product code JGS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ION-SPECIFIC ELECTRODE OPTION FOR COBAS FARA?

ION-SPECIFIC ELECTRODE OPTION FOR COBAS FARA is a medical device that received FDA 510(k) clearance on 1985-07-12. The listed applicant is Roche Diagnostic Systems, Inc.. The 510(k) number is K852473.

When did ION-SPECIFIC ELECTRODE OPTION FOR COBAS FARA receive FDA 510(k) clearance?

ION-SPECIFIC ELECTRODE OPTION FOR COBAS FARA received FDA 510(k) clearance on 1985-07-12, under 510(k) number K852473.

Who is the listed applicant for ION-SPECIFIC ELECTRODE OPTION FOR COBAS FARA?

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 ION-SPECIFIC ELECTRODE OPTION FOR COBAS FARA?

The FDA product code for ION-SPECIFIC ELECTRODE OPTION FOR COBAS FARA is JGS.

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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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