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FDA 510(k)

CONTROL PLASMA N AND CONTROL PLASMA P

K-Number: K042209 · 2004-10-21

ApplicantDade Behring, Inc.
Decision Date2004-10-21
Product CodeGGN
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CONTROL PLASMA N AND CONTROL PLASMA P is the device name listed in this FDA 510(k) record. The listed applicant is Dade Behring, Inc.. It received FDA 510(k) clearance on 2004-10-21 under 510(k) number K042209. The device is classified under product code GGN. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CONTROL PLASMA N AND CONTROL PLASMA P?

CONTROL PLASMA N AND CONTROL PLASMA P is a medical device that received FDA 510(k) clearance on 2004-10-21. The listed applicant is Dade Behring, Inc.. The 510(k) number is K042209.

When did CONTROL PLASMA N AND CONTROL PLASMA P receive FDA 510(k) clearance?

CONTROL PLASMA N AND CONTROL PLASMA P received FDA 510(k) clearance on 2004-10-21, under 510(k) number K042209.

Who is the listed applicant for CONTROL PLASMA N AND CONTROL PLASMA P?

The FDA 510(k) record lists Dade Behring, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CONTROL PLASMA N AND CONTROL PLASMA P?

The FDA product code for CONTROL PLASMA N AND CONTROL PLASMA P is GGN.

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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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