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FDA 510(k)

HUMAN PLASMA CONTROL FOR CEA-ROCHE

K-Number: K822219 · 1982-12-28

ApplicantHoffmann-La Roche, Inc.
Decision Date1982-12-28
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HUMAN PLASMA CONTROL FOR CEA-ROCHE 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 1982-12-28 under 510(k) number K822219. The device is classified under product code JJX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HUMAN PLASMA CONTROL FOR CEA-ROCHE?

HUMAN PLASMA CONTROL FOR CEA-ROCHE is a medical device that received FDA 510(k) clearance on 1982-12-28. The listed applicant is Hoffmann-La Roche, Inc.. The 510(k) number is K822219.

When did HUMAN PLASMA CONTROL FOR CEA-ROCHE receive FDA 510(k) clearance?

HUMAN PLASMA CONTROL FOR CEA-ROCHE received FDA 510(k) clearance on 1982-12-28, under 510(k) number K822219.

Who is the listed applicant for HUMAN PLASMA CONTROL FOR CEA-ROCHE?

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 HUMAN PLASMA CONTROL FOR CEA-ROCHE?

The FDA product code for HUMAN PLASMA CONTROL FOR CEA-ROCHE is JJX.

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

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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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