Cleared Traditional

VIRGO BETA 2 GLYCOPROTEIN IGM ANTIBODY KIT

K992243 · Hemagen Diagnostics, Inc. · Immunology
Aug 1999
Decision
60d
Days
Class 2
Risk

About This 510(k) Submission

K992243 is an FDA 510(k) clearance for the VIRGO BETA 2 GLYCOPROTEIN IGM ANTIBODY KIT, a System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi) (Class II — Special Controls, product code MSV), submitted by Hemagen Diagnostics, Inc. (Waltham, US). The FDA issued a Cleared decision on August 30, 1999, 60 days after receiving the submission on July 1, 1999. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5660.

Submission Details

510(k) Number K992243 FDA.gov
FDA Decision Cleared SESE
Date Received July 01, 1999
Decision Date August 30, 1999
Days to Decision 60 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code MSV — System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5660

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