FDA 510(k)

COBAS STANDARD FOR TOTAL PROTEIN

K-Number: K823576 · 1983-01-07

Decision Date1983-01-07

Product CodeLER

Advisory CommitteeTX

DecisionSubstantially Equivalent

Device Summary

COBAS STANDARD FOR TOTAL PROTEIN 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 K823576. The device is classified under product code LER. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COBAS STANDARD FOR TOTAL PROTEIN?

COBAS STANDARD FOR TOTAL PROTEIN 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 K823576.

When did COBAS STANDARD FOR TOTAL PROTEIN receive FDA 510(k) clearance?

COBAS STANDARD FOR TOTAL PROTEIN received FDA 510(k) clearance on 1983-01-07, under 510(k) number K823576.

Who is the listed applicant for COBAS STANDARD FOR TOTAL PROTEIN?

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 STANDARD FOR TOTAL PROTEIN?

The FDA product code for COBAS STANDARD FOR TOTAL PROTEIN is LER.

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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.