GSP NEONATAL 17A-OH-PROGESTERONE KIT MODEL: 3305-001U— 510(k) K100682

Name: FDA 510(k) clearance K100682
Creator: U.S. Food and Drug Administration
Published: 2010-07-23

Substantially Equivalent

Wallac OY

FDA 510(k) clearance K100682 for GSP NEONATAL 17A-OH-PROGESTERONE KIT MODEL: 3305-001U, Substantially Equivalent on 2010-07-23. 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: 2010-03-10
Decision date: 2010-07-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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