Cleared Traditional

TRUST RPR CARD TEST #65144

K832479 · Emd Chemicals, Inc. · Hematology
Sep 1983
Decision
48d
Days
Class 2
Risk

About This 510(k) Submission

K832479 is an FDA 510(k) clearance for the TRUST RPR CARD TEST #65144, a Antigens, Nontreponemal, All (Class II — Special Controls, product code GMQ), submitted by Emd Chemicals, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 12, 1983, 48 days after receiving the submission on July 26, 1983. This device falls under the Hematology review panel. Regulated under 21 CFR 866.3820.

Submission Details

510(k) Number K832479 FDA.gov
FDA Decision Cleared SESE
Date Received July 26, 1983
Decision Date September 12, 1983
Days to Decision 48 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

Product Code GMQ — Antigens, Nontreponemal, All
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3820

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