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

Name: FDA 510(k) clearance K081922
Creator: U.S. Food and Drug Administration
Published: 2009-04-16

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. Device class: 1.

Clearance details

Applicant: Wallac OY
Product code: Code JLX
Device class: Class 1
Regulation: 21 CFR 862.1395
Advisory panel: Clinical Chemistry
Date received: 2008-07-07
Decision date: 2009-04-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Turku, FI

Download summary PDF View on FDA.gov ↗

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K060452 — ACCUWELL 17-ALPHA-HYDROXYPROESTERONE ENZYME IMMUNOASSAY WITH MODELS 6015XX-ECAH2007-03-13
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