AUTOSTAT II ANTI-CARDIOLIPIN IGA ELISA— 510(k) K030741

Name: FDA 510(k) clearance K030741
Creator: U.S. Food and Drug Administration
Published: 2003-05-01

Substantially Equivalent

Hycor Biomedical , Ltd.

FDA 510(k) clearance K030741 for AUTOSTAT II ANTI-CARDIOLIPIN IGA ELISA, Substantially Equivalent on 2003-05-01. Applicant: Hycor Biomedical , Ltd.. Device class: 2.

Clearance details

Applicant: Hycor Biomedical , Ltd.
Product code: Code MID
Device class: Class 2
Regulation: 21 CFR 866.5660
Advisory panel: Immunology
Date received: 2003-03-10
Decision date: 2003-05-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Penicuik, Midlothian, GB

Download summary PDF View on FDA.gov ↗

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