Cleared Traditional

MODIFIED QM300 RHEUMATOID FACTOR TEST

K902462 · Kallestad Diag, A Div. of Erbamont, Inc. · Immunology
Jun 1990
Decision
17d
Days
Class 2
Risk

About This 510(k) Submission

K902462 is an FDA 510(k) clearance for the MODIFIED QM300 RHEUMATOID FACTOR TEST, a System, Test, Rheumatoid Factor (Class II — Special Controls, product code DHR), submitted by Kallestad Diag, A Div. of Erbamont, Inc. (Chaska, US). The FDA issued a Cleared decision on June 21, 1990, 17 days after receiving the submission on June 4, 1990. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5775.

Submission Details

510(k) Number K902462 FDA.gov
FDA Decision Cleared SESE
Date Received June 04, 1990
Decision Date June 21, 1990
Days to Decision 17 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary —

Device Classification

Product Code DHR — System, Test, Rheumatoid Factor
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5775

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