Multifibren U

FDA 510(k) K934326 · Behring Diagnostics, Inc.

Substantially Equivalent

510(k) numberK934326

Submission

Device name
Multifibren U
Applicant
Behring Diagnostics, Inc.
Westwood, MA, US
Received
September 3, 1993
Decision date
April 19, 1994
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
KQJ – System, Fibrinogen Determination
Device class
Class II (moderate risk)
Regulation
21 CFR 864.7340
Specialty
Hematology

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K073367Hemosil Fibrinogen-CKQJ · Special Instrumentation Laboratory CO12/27/2007SE
K050928Dade Thrombin ReagentKQJ · Traditional Dade Behring, Inc.06/29/2005SE
K971858Sigma Diagnostics Fibrinogen Kit (886A/887A)KQJ · Traditional Sigma Diagnostics, Inc.10/09/1997SE
K970189Fif TMKQJ · Traditional Panbio, Inc.05/21/1997SE
K965113N-Assay Tia Fibrinogen Test KitKQJ · Traditional Crestat Diagnostics, Inc.04/16/1997SE
K931721Il Test Fibrinogen-CKQJ · Traditional Instrumentation Laboratory CO08/13/1993SE
K922416Fibrinogen Rid Test KitKQJ · Traditional The Binding Site, Ltd.03/09/1993SE
K925988MultifibrenKQJ · Traditional Behring Diagnostics, Inc.03/01/1993SE
K923593Hemochron/Factor Vi Fibrinogen Assay and Cont PlasKQJ · Traditional International Technidyne Corp.09/22/1992SE

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Questions and answers

When was Multifibren U cleared by the FDA?

Multifibren U (K934326) received a 510(k) decision of Substantially Equivalent on April 19, 1994, 228 days after the submission was received.

What is the product code of K934326?

The FDA product code is KQJ – System, Fibrinogen Determination, a Class II (moderate risk) device regulated under 21 CFR 864.7340.