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FDA 510(k)

COBAS STANDARDS FOR ALBUMIN

K-Number: K823575 · 1983-01-07

ApplicantHoffmann-La Roche, Inc.
Decision Date1983-01-07
Product CodeCIX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

COBAS STANDARDS FOR ALBUMIN is the device name listed in this FDA 510(k) record. The listed applicant is Hoffmann-La Roche, Inc.. It received FDA 510(k) clearance on 1983-01-07 under 510(k) number K823575. The device is classified under product code CIX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COBAS STANDARDS FOR ALBUMIN?

COBAS STANDARDS FOR ALBUMIN is a medical device that received FDA 510(k) clearance on 1983-01-07. The listed applicant is Hoffmann-La Roche, Inc.. The 510(k) number is K823575.

When did COBAS STANDARDS FOR ALBUMIN receive FDA 510(k) clearance?

COBAS STANDARDS FOR ALBUMIN received FDA 510(k) clearance on 1983-01-07, under 510(k) number K823575.

Who is the listed applicant for COBAS STANDARDS FOR ALBUMIN?

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

What is the FDA product code for COBAS STANDARDS FOR ALBUMIN?

The FDA product code for COBAS STANDARDS FOR ALBUMIN is CIX.

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Other records listing Hoffmann-La Roche, Inc. as applicant

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Related Devices (Code: CIX)

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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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