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FDA 510(k)

CONTROL PLASMA N

K-Number: K023309 · 2002-11-01

ApplicantDade Behring, Inc.
Decision Date2002-11-01
Product CodeGIZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CONTROL PLASMA N 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 2002-11-01 under 510(k) number K023309. The device is classified under product code GIZ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CONTROL PLASMA N?

CONTROL PLASMA N is a medical device that received FDA 510(k) clearance on 2002-11-01. The listed applicant is Dade Behring, Inc.. The 510(k) number is K023309.

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

CONTROL PLASMA N received FDA 510(k) clearance on 2002-11-01, under 510(k) number K023309.

Who is the listed applicant for CONTROL PLASMA N?

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?

The FDA product code for CONTROL PLASMA N is GIZ.

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Other records listing Dade Behring, Inc. as applicant

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Related Devices (Code: GIZ)

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.

K060968STASIS - I, II AND III; SERATHAN - A, B; INTRIN - EA, SI CALCIUM CHLORIDE 0.02M; FIBRINOGEN CONTROL-NORMAL, LOWWortham Laboratories, Inc.K042941DADE BEHRING HEPARIN CALIBRATOR AND CONTROLSDade Behring, Inc.K013708REFERENCE CHECK, CATALOG NUMBER-RCN-10Precision BiologicK003328ACCUCLOT CONTROL I, MODEL A4089Sigma Diagnostics, Inc.K001256CONTROL PLASMA NDade Behring, Inc.K984129COAGULATION CONTROL LEVEL 1 (NORMAL)Pacific Hemostasis

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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