Cleared Traditional

AUTODELFIA NEONATAL IRT KIT, MODEL B005-112

K003668 · Wallac OY · Chemistry
Feb 2001
Decision
76d
Days
Class 2
Risk

About This 510(k) Submission

K003668 is an FDA 510(k) clearance for the AUTODELFIA NEONATAL IRT KIT, MODEL B005-112, 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 February 12, 2001, 76 days after receiving the submission on November 28, 2000. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1170.

Submission Details

510(k) Number K003668 FDA.gov
FDA Decision Cleared SESE
Date Received November 28, 2000
Decision Date February 12, 2001
Days to Decision 76 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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