Virgo Beta 2 Glycoprotein Igg Antibody Kit

Q: What is the product code of K992224?

The FDA product code is MSV – System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi), a Class II (moderate risk) device regulated under 21 CFR 866.5660.

FDA 510(k) K992224 · Hemagen Diagnostics, Inc.

Substantially Equivalent

510(k) numberK992224

Submission

Device name: Virgo Beta 2 Glycoprotein Igg Antibody Kit
Applicant: Hemagen Diagnostics, Inc.
Waltham, MA, US
Received: July 1, 1999
Decision date: August 30, 1999
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: MSV – System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)
Device class: Class II (moderate risk)
Regulation: 21 CFR 866.5660
Specialty: Immunology

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Questions and answers

When was Virgo Beta 2 Glycoprotein Igg Antibody Kit cleared by the FDA?

Virgo Beta 2 Glycoprotein Igg Antibody Kit (K992224) received a 510(k) decision of Substantially Equivalent on August 30, 1999, 60 days after the submission was received.

What is the product code of K992224?

The FDA product code is MSV – System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi), a Class II (moderate risk) device regulated under 21 CFR 866.5660.