Cleared Traditional

WAKO TOTAL BILIRUBIN V, MODELS 410-22701, 998-23291, 416-22801, 990-23191

K053131 · Wako Chemicals USA, Inc. · Chemistry
Dec 2005
Decision
52d
Days
Class 2
Risk

About This 510(k) Submission

K053131 is an FDA 510(k) clearance for the WAKO TOTAL BILIRUBIN V, MODELS 410-22701, 998-23291, 416-22801, 990-23191, a Enzymatic Method, Bilirubin (Class II — Special Controls, product code JFM), submitted by Wako Chemicals USA, Inc. (Richmond, US). The FDA issued a Cleared decision on December 30, 2005, 52 days after receiving the submission on November 8, 2005. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1110.

Submission Details

510(k) Number K053131 FDA.gov
FDA Decision Cleared SESE
Date Received November 08, 2005
Decision Date December 30, 2005
Days to Decision 52 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JFM — Enzymatic Method, Bilirubin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1110

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