Human Protein S Rid Test Kit

Q: What is the product code of K951640?

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) K951640 · The Binding Site, Ltd.

Substantially Equivalent

510(k) numberK951640

Submission

Device name: Human Protein S Rid Test Kit
Applicant: The Binding Site, Ltd.
Santa Monica, CA, US
Received: April 10, 1995
Decision date: April 21, 1997
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) statement 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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Questions and answers

When was Human Protein S Rid Test Kit cleared by the FDA?

Human Protein S Rid Test Kit (K951640) received a 510(k) decision of Substantially Equivalent on April 21, 1997, 742 days after the submission was received.

What is the product code of K951640?

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