Bovine Factor Xa-Human Factor Xa

FDA 510(k) K841957 · Haemachem, Inc.

Substantially Equivalent

510(k) numberK841957

Submission

Device name
Bovine Factor Xa-Human Factor Xa
Applicant
Haemachem, Inc.
Mchenry, IL, US
Received
May 14, 1984
Decision date
July 19, 1984
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
GGP – Test, Qualitative And Quantitative Factor Deficiency
Device class
Class II (moderate risk)
Regulation
21 CFR 864.7290
Specialty
Hematology

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More from Instrumentation Laboratory CO

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K903874Fibrinotest(Tm) - Fibrinogen AssayGIS · Traditional 02/14/1991SE
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Questions and answers

When was Bovine Factor Xa-Human Factor Xa cleared by the FDA?

Bovine Factor Xa-Human Factor Xa (K841957) received a 510(k) decision of Substantially Equivalent on July 19, 1984, 66 days after the submission was received.

What is the product code of K841957?

The FDA product code is GGP – Test, Qualitative And Quantitative Factor Deficiency, a Class II (moderate risk) device regulated under 21 CFR 864.7290.