Cleared Traditional

QUANTIMETRIC PLUS CALIBRATOR/CONTROL SET A

K855014 · Kallestad Laboratories, Inc. · Immunology
Mar 1986
Decision
88d
Days
Class 2
Risk

About This 510(k) Submission

K855014 is an FDA 510(k) clearance for the QUANTIMETRIC PLUS CALIBRATOR/CONTROL SET A, a Calibrator, Multi-analyte Mixture (Class II — Special Controls, product code JIX), submitted by Kallestad Laboratories, Inc. (Chaska, US). The FDA issued a Cleared decision on March 14, 1986, 88 days after receiving the submission on December 16, 1985. This device falls under the Immunology review panel. Regulated under 21 CFR 862.1150.

Submission Details

510(k) Number K855014 FDA.gov
FDA Decision Cleared SESE
Date Received December 16, 1985
Decision Date March 14, 1986
Days to Decision 88 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary —

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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