Cleared Traditional

QM300 CONTROL E

K883537 · Kallestad Diag, A Div. of Erbamont, Inc. · Immunology
Nov 1988
Decision
78d
Days
Class 2
Risk

About This 510(k) Submission

K883537 is an FDA 510(k) clearance for the QM300 CONTROL E, a System, Test, Radioallergosorbent (rast) Immunological (Class II — Special Controls, product code DHB), submitted by Kallestad Diag, A Div. of Erbamont, Inc. (Chaska, US). The FDA issued a Cleared decision on November 4, 1988, 78 days after receiving the submission on August 18, 1988. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5750.

Submission Details

510(k) Number K883537 FDA.gov
FDA Decision Cleared SESE
Date Received August 18, 1988
Decision Date November 04, 1988
Days to Decision 78 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary —

Device Classification

Product Code DHB — System, Test, Radioallergosorbent (rast) Immunological
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5750

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