ACL/APS FACS KIT— 510(k) K984102

Name: FDA 510(k) clearance K984102
Creator: U.S. Food and Drug Administration
Published: 1999-03-18

Substantially Equivalent

Louisville Apl Diagnostics, Inc.

FDA 510(k) clearance K984102 for ACL/APS FACS KIT, Substantially Equivalent on 1999-03-18. Applicant: Louisville Apl Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Louisville Apl Diagnostics, Inc.
Product code: Code MID
Device class: Class 2
Regulation: 21 CFR 866.5660
Advisory panel: Immunology
Date received: 1998-11-17
Decision date: 1999-03-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Doraville, GA, 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 Louisville Apl Diagnostics, Inc.

view all

K021398 — APL IGA ELISA KIT2002-08-27
K933588 — APHLELISA KIT1994-10-13

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