Cleared Traditional

IMMUNOWELL CARDIOLIPIN ANTIBODY (IGM) TEST

K920401 · General Biometrics, Inc. · Immunology
Aug 1992
Decision
204d
Days
Class 2
Risk

About This 510(k) Submission

K920401 is an FDA 510(k) clearance for the IMMUNOWELL CARDIOLIPIN ANTIBODY (IGM) TEST, a System, Test, Anticardiolipin Immunological (Class II — Special Controls, product code MID), submitted by General Biometrics, Inc. (San Diego, US). The FDA issued a Cleared decision on August 20, 1992, 204 days after receiving the submission on January 29, 1992. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5660.

Submission Details

510(k) Number K920401 FDA.gov
FDA Decision Cleared SESE
Date Received January 29, 1992
Decision Date August 20, 1992
Days to Decision 204 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

Device Classification

Product Code MID — System, Test, Anticardiolipin Immunological
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5660

Similar Devices — MID System, Test, Anticardiolipin Immunological

All 93
Aptiva APS IgG Reagent; Aptiva APS IgM Reagent
K223093 · Inova Diagnostics, Inc. · Dec 2024
ELIA(TM) CARDIOLIPIN IGA IMMUNOASSAY
K131821 · Phadia US, Inc. · Dec 2013
BIOPLEX 2200 APLS IGM
K130528 · Bio-Rad Laboratories · Oct 2013
QUANTA FLASH ACL LGA, QUANTA FLASH B2GP1 IGA
K120817 · Inova Diagnostics, Inc. · Feb 2013
IMMULISA ENHANCED (TM) CARDIOLIPIN IGA, IGG, IGM AND IGA/IGG/IGM ANTIBODY (ACA) ELISAS
K113020 · Immco Diagnostics, Inc. · Oct 2012
BIOPLEX 2200 APLS IGG AND IGA KIT AND CALIBRATOR AND CONTROL SETS
K103834 · Bio-Rad Laboratories · Mar 2012