Cleared Traditional

QM300 CALIBRATOR D PACK

K883001 · Kallestad Diag, A Div. of Erbamont, Inc. · Immunology
Sep 1988
Decision
66d
Days
Class 2
Risk

About This 510(k) Submission

K883001 is an FDA 510(k) clearance for the QM300 CALIBRATOR D PACK, a Igd, Antigen, Antiserum, Control (Class II — Special Controls, product code CZJ), submitted by Kallestad Diag, A Div. of Erbamont, Inc. (Chaska, US). The FDA issued a Cleared decision on September 22, 1988, 66 days after receiving the submission on July 18, 1988. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5510.

Submission Details

510(k) Number K883001 FDA.gov
FDA Decision Cleared SESE
Date Received July 18, 1988
Decision Date September 22, 1988
Days to Decision 66 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary —

Device Classification

Product Code CZJ — Igd, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5510

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