510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K031208Substantially Equivalent

Reaads Igm Anti-B2gpi Test Kit, Model 038-001

Corgenix, Inc., Westminster CO / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K031208 is the FDA 510(k) clearance record for REAADS IGM ANTI-B2GPI TEST KIT, MODEL 038-001, a class II device, cleared for Corgenix, Inc. on under FDA product code MSV (System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)). FDA records list 23 510(k) clearances for Corgenix, Inc., from to . As of , FDA records show no recalls naming K031208.

Clearance record

Decision date
Received
(81 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
Corgenix, Inc. 12061 Tejon St., Westminster CO
510(k) summary
Statement
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