Universal Reagent Factor Xii (Twelve) Deficient Plasma

Q: What is the product code of K973143?

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

FDA 510(k) K973143 · Universal Reagents, Inc.

Substantially Equivalent

510(k) numberK973143

Submission

Device name: Universal Reagent Factor Xii (Twelve) Deficient Plasma
Applicant: Universal Reagents, Inc.
Indianapolis, IN, US
Received: August 22, 1997
Decision date: September 25, 1997
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

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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K133005	Hemosil Von Willebrand Activity AssayGGP · Special	Instrumentation Laboratory CO	03/13/2014SE

More from Instrumentation Laboratory CO

510(k)	Device	Decision
K972288	Factor Deficient Plasmas - Factor Ix (9)GGP · Traditional	07/14/1997SE
K972286	Factor Deficient Plasmas - Factor Xi (11)GJT · Traditional	07/14/1997SE
K970607	Universal Reagent Factor Vii Deficient PlasmaGJT · Traditional	04/25/1997SE
K970593	Universal Reagent Factor Viii Deficient PlasmaGJT · Traditional	04/25/1997SE
K964459	Universal Reagent Factor X Deficient PlasmaGGP · Traditional	12/18/1996SE
K964270	Universal Reagent Factor V Deficient PlasmaGGP · Traditional	12/18/1996SE
K961929	Factor Deficient PlasmaGGP · Traditional	10/10/1996SE

Questions and answers

When was Universal Reagent Factor Xii (Twelve) Deficient Plasma cleared by the FDA?

Universal Reagent Factor Xii (Twelve) Deficient Plasma (K973143) received a 510(k) decision of Substantially Equivalent on September 25, 1997, 34 days after the submission was received.

What is the product code of K973143?

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