Cleared Traditional

K-ASSAY MULTI-ANALYTE CALIBRATOR

K993853 · Kamiya Biomedical Co. · Chemistry
Dec 1999
Decision
45d
Days
Class 2
Risk

About This 510(k) Submission

K993853 is an FDA 510(k) clearance for the K-ASSAY MULTI-ANALYTE CALIBRATOR, a Calibrator, Multi-analyte Mixture (Class II — Special Controls, product code JIX), submitted by Kamiya Biomedical Co. (Seattle, US). The FDA issued a Cleared decision on December 27, 1999, 45 days after receiving the submission on November 12, 1999. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1150.

Submission Details

510(k) Number K993853 FDA.gov
FDA Decision Cleared SESE
Date Received November 12, 1999
Decision Date December 27, 1999
Days to Decision 45 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JIX — Calibrator, Multi-analyte Mixture
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1150

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