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FDA 510(k)

COBAS STANDARDS FOR GLUCOSE & BUN

K-Number: K831030 · 1983-05-09

ApplicantRoche Diagnostic Systems, Inc.
Decision Date1983-05-09
Product CodeJIX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

COBAS STANDARDS FOR GLUCOSE & BUN 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 1983-05-09 under 510(k) number K831030. 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 COBAS STANDARDS FOR GLUCOSE & BUN?

COBAS STANDARDS FOR GLUCOSE & BUN is a medical device that received FDA 510(k) clearance on 1983-05-09. The listed applicant is Roche Diagnostic Systems, Inc.. The 510(k) number is K831030.

When did COBAS STANDARDS FOR GLUCOSE & BUN receive FDA 510(k) clearance?

COBAS STANDARDS FOR GLUCOSE & BUN received FDA 510(k) clearance on 1983-05-09, under 510(k) number K831030.

Who is the listed applicant for COBAS STANDARDS FOR GLUCOSE & BUN?

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 COBAS STANDARDS FOR GLUCOSE & BUN?

The FDA product code for COBAS STANDARDS FOR GLUCOSE & BUN is 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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