510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K992224Substantially Equivalent

Virgo Beta 2 Glycoprotein Igg Antibody Kit

Hemagen Diagnostics, Inc., Waltham MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K992224 is the FDA 510(k) clearance record for VIRGO BETA 2 GLYCOPROTEIN IGG ANTIBODY KIT, a class II device, cleared for Hemagen Diagnostics, Inc. on under FDA product code MSV (System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)). FDA records list 52 510(k) clearances for Hemagen Diagnostics, Inc., from to . As of , FDA records show no recalls naming K992224.

Clearance record

Decision date
Received
(60 days to decision)
Product code
MSV System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)
Regulation
21 CFR 866.5660
Device class
Class II
Review panel
Immunology
Applicant
Hemagen Diagnostics, Inc. 40 Bear Hill Rd., Waltham MA
510(k) summary
Summary
Third party review
No

Clearances, product code MSV

Trailing 12 months
1 clearance under product code MSV in the twelve months to October 2026, February 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MSV, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20261
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260