AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KIT— 510(k) K081922

Substantially Equivalent

Wallac OY

FDA 510(k) clearance K081922 for AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KIT, Substantially Equivalent on 2009-04-16. Applicant: Wallac OY.

Clearance details

Applicant: Wallac OY
Product code: Code JLX
Advisory panel: Clinical Chemistry
Date received: 2008-07-07
Decision date: 2009-04-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Turku, FI

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