DELFIA NEONATAL IRT KIT, MODEL A005-110— 510(k) K003664

Substantially Equivalent

Wallac OY

FDA 510(k) clearance K003664 for DELFIA NEONATAL IRT KIT, MODEL A005-110, Substantially Equivalent on 2001-02-14. Applicant: Wallac OY.

Clearance details

Applicant: Wallac OY
Product code: Code CGZ
Advisory panel: Clinical Chemistry
Date received: 2000-11-28
Decision date: 2001-02-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Turku, FI

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