AESKUSLIDES ANA HEP-2— 510(k) K120889

Substantially Equivalent

Aesku Diagnostics

FDA 510(k) clearance K120889 for AESKUSLIDES ANA HEP-2, Substantially Equivalent on 2012-10-15. Applicant: Aesku Diagnostics. Device class: 2.

Clearance details

Applicant: Aesku Diagnostics
Product code: Code DHN
Device class: Class 2
Regulation: 21 CFR 866.5100
Advisory panel: Immunology
Date received: 2012-03-23
Decision date: 2012-10-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pedricktown, NJ, US

Download summary PDF View on FDA.gov ↗

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More clearances from Aesku Diagnostics

K132082 — AESKULISA DGP-A, AESKULISA DGP-G,AESKULISA DGP-CHECK2013-12-05
K091859 — AESKU PR32010-06-03
K091860 — AESKULISA MPO, MODEL 30-7303US2010-02-23
K081251 — MODIFICATION TO AESKULISA DS DNA G2008-05-13
K081104 — AESKULISA ANA HEP-2, REF 30-7115US2008-05-02

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