MODIFICATION TO: REAADS ANTI-PHOSPHATIDYLSERINE IGG/IGM SEMI-QUANTITATIVE TEST KIT— 510(k) K012567

Name: FDA 510(k) clearance K012567
Creator: U.S. Food and Drug Administration
Published: 2001-08-23

Substantially Equivalent

Corgenix, Inc.

FDA 510(k) clearance K012567 for MODIFICATION TO: REAADS ANTI-PHOSPHATIDYLSERINE IGG/IGM SEMI-QUANTITATIVE TEST KIT, Substantially Equivalent on 2001-08-23. Applicant: Corgenix, Inc.. Device class: 2.

Clearance details

Applicant: Corgenix, Inc.
Product code: Code MID
Device class: Class 2
Regulation: 21 CFR 866.5660
Advisory panel: Immunology
Date received: 2001-08-09
Decision date: 2001-08-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Westminster, CO, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MID

view all

K223093 — Aptiva APS IgG Reagent; Aptiva APS IgM Reagent2024-12-17
K131821 — ELIA(TM) CARDIOLIPIN IGA IMMUNOASSAY2013-12-23
K130528 — BIOPLEX 2200 APLS IGM2013-10-21
K120817 — QUANTA FLASH ACL LGA, QUANTA FLASH B2GP1 IGA2013-02-26
K113020 — IMMULISA ENHANCED (TM) CARDIOLIPIN IGA, IGG, IGM AND IGA/IGG/IGM ANTIBODY (ACA) ELISAS2012-10-25

More clearances from Corgenix, Inc.

view all

K072032 — IGG ANTI-ATHEROX TEST KIT2008-04-04
K062025 — ASPIRINWORKS TEST KIT (11-DEHYDRO THROMBOXANE B2), MODEL 121362007-05-29
K042680 — RHIGENE HEP-ANA TEST SYSTEM2004-11-19
K032139 — REAADS VON WILLEBRAND FACTOR ACTIVITY TEST KIT, MODEL 108262004-04-05
K034013 — REAADS DSDNA QUANTITATIVE TEST KIT, MODEL 022-0012004-01-08

Data sourced from openFDA. This site is unofficial and independent of the FDA.