Cleared Traditional

AUTO DELFIA

K935047 · Wallac OY · Chemistry
May 1994
Decision
214d
Days
Class 1
Risk

About This 510(k) Submission

K935047 is an FDA 510(k) clearance for the AUTO DELFIA, a Fluorometer, For Clinical Use (Class I — General Controls, product code KHO), submitted by Wallac OY (Finland, FI). The FDA issued a Cleared decision on May 23, 1994, 214 days after receiving the submission on October 21, 1993. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2560.

Submission Details

510(k) Number K935047 FDA.gov
FDA Decision Cleared SESE
Date Received October 21, 1993
Decision Date May 23, 1994
Days to Decision 214 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code KHO — Fluorometer, For Clinical Use
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.2560

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