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FDA 510(k)

ROCHE STANDARDS FOR CHLORIDE & CO2

K-Number: K850396 · 1985-02-27

ApplicantRoche Diagnostic Systems, Inc.
Decision Date1985-02-27
Product CodeJIX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ROCHE STANDARDS FOR CHLORIDE & CO2 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 1985-02-27 under 510(k) number K850396. The device is classified under product code JIX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROCHE STANDARDS FOR CHLORIDE & CO2?

ROCHE STANDARDS FOR CHLORIDE & CO2 is a medical device that received FDA 510(k) clearance on 1985-02-27. The listed applicant is Roche Diagnostic Systems, Inc.. The 510(k) number is K850396.

When did ROCHE STANDARDS FOR CHLORIDE & CO2 receive FDA 510(k) clearance?

ROCHE STANDARDS FOR CHLORIDE & CO2 received FDA 510(k) clearance on 1985-02-27, under 510(k) number K850396.

Who is the listed applicant for ROCHE STANDARDS FOR CHLORIDE & CO2?

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 STANDARDS FOR CHLORIDE & CO2?

The FDA product code for ROCHE STANDARDS FOR CHLORIDE & CO2 is JIX.

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Related Devices (Code: JIX)

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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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