Cleared Traditional

SPOTCHEM II TOTAL BILIRUBIN, TOTAL PROTEIN AND ALBUMIN TESTS

K051432 · Arkray, Inc. · Chemistry
Jun 2005
Decision
16d
Days
Class 2
Risk

About This 510(k) Submission

K051432 is an FDA 510(k) clearance for the SPOTCHEM II TOTAL BILIRUBIN, TOTAL PROTEIN AND ALBUMIN TESTS, a Diazo Colorimetry, Bilirubin (Class II — Special Controls, product code CIG), submitted by Arkray, Inc. (Cortlandt Manor, US). The FDA issued a Cleared decision on June 17, 2005, 16 days after receiving the submission on June 1, 2005. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1110.

Submission Details

510(k) Number K051432 FDA.gov
FDA Decision Cleared SESE
Date Received June 01, 2005
Decision Date June 17, 2005
Days to Decision 16 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CIG — Diazo Colorimetry, Bilirubin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1110

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