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FDA 510(k)

CONTROL PLASMA N, PROC CONTROL PLASMA

K-Number: K042333 · 2004-12-01

Decision Date2004-12-01
Product CodeGGN
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CONTROL PLASMA N, PROC CONTROL PLASMA 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 2004-12-01 under 510(k) number K042333. 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, PROC CONTROL PLASMA?

CONTROL PLASMA N, PROC CONTROL PLASMA is a medical device that received FDA 510(k) clearance on 2004-12-01. The listed applicant is Dade Behring, Inc.. The 510(k) number is K042333.

When did CONTROL PLASMA N, PROC CONTROL PLASMA receive FDA 510(k) clearance?

CONTROL PLASMA N, PROC CONTROL PLASMA received FDA 510(k) clearance on 2004-12-01, under 510(k) number K042333.

Who is the listed applicant for CONTROL PLASMA N, PROC CONTROL PLASMA?

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, PROC CONTROL PLASMA?

The FDA product code for CONTROL PLASMA N, PROC CONTROL PLASMA is GGN.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Other records listing Dade Behring, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: GGN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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