DELFIA(R) HGH KIT— 510(k) K930484

Substantially Equivalent

Wallac OY

FDA 510(k) clearance K930484 for DELFIA(R) HGH KIT, Substantially Equivalent on 1993-05-11. Applicant: Wallac OY. Device class: 1.

Clearance details

Applicant: Wallac OY
Product code: Product code CFL
Device class: Class 1
Regulation: 21 CFR 862.1370
Advisory panel: Clinical Chemistry
Date received: 1993-01-29
Decision date: 1993-05-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Finland, FI

Download summary PDF View on FDA.gov ↗

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