Cleared Traditional

DELFIA NEONATAL IRT KIT

K993697 · Wallac OY · Chemistry
Jun 2000
Decision
220d
Days
Class 2
Risk

About This 510(k) Submission

K993697 is an FDA 510(k) clearance for the DELFIA NEONATAL IRT KIT, a Electrode, Ion-specific, Chloride (Class II — Special Controls, product code CGZ), submitted by Wallac OY (Turku, FI). The FDA issued a Cleared decision on June 9, 2000, 220 days after receiving the submission on November 2, 1999. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1170.

Submission Details

510(k) Number K993697 FDA.gov
FDA Decision Cleared SESE
Date Received November 02, 1999
Decision Date June 09, 2000
Days to Decision 220 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CGZ — Electrode, Ion-specific, Chloride
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1170

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