510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K001398Substantially Equivalent

Reaads Igm Anti-Prothrombin Semi-Quantitative Test Kit

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

K001398 is the FDA 510(k) clearance record for REAADS IGM ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT, a class II device, cleared for Corgenix, Inc. on under FDA product code DHC (System, Test, Systemic Lupus Erythematosus). FDA records list 23 510(k) clearances for Corgenix, Inc., from to . As of , FDA records show no recalls naming K001398.

Clearance record

Decision date
Received
(331 days to decision)
Product code
DHC System, Test, Systemic Lupus Erythematosus
Regulation
21 CFR 866.5820
Device class
Class II
Review panel
Immunology
Applicant
Corgenix, Inc. 12061 Tejon St., Westminster CO
510(k) summary
Summary
Third party review
No

Clearances, product code DHC

Trailing 12 months

FDA records hold no clearances under product code DHC in the trailing twelve months.

FDA records show no clearances under product code DHC in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DHC, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260