Cleared Traditional

K-ASSAY APO A1/B CALIBRATOR SET

K993606 · Kamiya Biomedical Co. · Chemistry
Nov 1999
Decision
32d
Days
Class 2
Risk

About This 510(k) Submission

K993606 is an FDA 510(k) clearance for the K-ASSAY APO A1/B CALIBRATOR SET, 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 November 26, 1999, 32 days after receiving the submission on October 25, 1999. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1150.

Submission Details

510(k) Number K993606 FDA.gov
FDA Decision Cleared SESE
Date Received October 25, 1999
Decision Date November 26, 1999
Days to Decision 32 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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