Cleared Traditional

QM300 PCR ANTIBODY PACK

K885001 · Kallestad Diag, A Div. of Erbamont, Inc. · Immunology
Dec 1988
Decision
19d
Days
Class 2
Risk

About This 510(k) Submission

K885001 is an FDA 510(k) clearance for the QM300 PCR ANTIBODY PACK, a System, Test, C-reactive Protein (Class II — Special Controls, product code DCN), submitted by Kallestad Diag, A Div. of Erbamont, Inc. (Chaska, US). The FDA issued a Cleared decision on December 20, 1988, 19 days after receiving the submission on December 1, 1988. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5270.

Submission Details

510(k) Number K885001 FDA.gov
FDA Decision Cleared SESE
Date Received December 01, 1988
Decision Date December 20, 1988
Days to Decision 19 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary —

Device Classification

Product Code DCN — System, Test, C-reactive Protein
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5270

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