ELIAS CARDIOLIPIN ANTIBODIES— 510(k) K940403

Name: FDA 510(k) clearance K940403
Creator: U.S. Food and Drug Administration
Published: 1994-09-20

Substantially Equivalent

Elias U.S.A., Inc.

FDA 510(k) clearance K940403 for ELIAS CARDIOLIPIN ANTIBODIES, Substantially Equivalent on 1994-09-20. Applicant: Elias U.S.A., Inc.. Device class: 2.

Clearance details

Applicant: Elias U.S.A., Inc.
Product code: Code MID
Device class: Class 2
Regulation: 21 CFR 866.5660
Advisory panel: Immunology
Date received: 1994-01-27
Decision date: 1994-09-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Osceola, WI, 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 Elias U.S.A., Inc.

view all

K964385 — ELIAS ANA-HEP-21997-03-06
K963291 — VARELISA ANA (4) PROFILE1996-09-30
K953873 — VARELISA HELICOBACTER PYLORI ANTIBODIES1996-08-30
K953586 — VARELISA PR3-ANCA1996-01-26
K953587 — VARELISA MPO-ANCA1996-01-26

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