AESKULISA CARDIOLIPIN AGM— 510(k) K040463

Substantially Equivalent

Aesku, Inc.

FDA 510(k) clearance K040463 for AESKULISA CARDIOLIPIN AGM, Substantially Equivalent on 2004-05-12. Applicant: Aesku, Inc.. Device class: 2.

Clearance details

Applicant: Aesku, Inc.
Product code: Code MID
Device class: Class 2
Regulation: 21 CFR 866.5660
Advisory panel: Immunology
Date received: 2004-02-23
Decision date: 2004-05-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

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More clearances from Aesku, Inc.

K062217 — AESKULSKA BETA2-GLYCO-A2006-12-13
K051492 — AESKULISA ASCA A2005-11-14
K042644 — AESKULISA TTG A AND AESKULISA TTG G2005-06-01
K040953 — AESKULISA ANA HEP-22004-06-23
K032469 — AESKULISA ANA 8PRO2003-12-16

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