Cleared Traditional

ELTRACHEM DIATRAC GLYCOSYLATED HEMOGLOB

K834294 · Emd Chemicals, Inc. · Hematology
Jan 1984
Decision
47d
Days
Class 2
Risk

About This 510(k) Submission

K834294 is an FDA 510(k) clearance for the ELTRACHEM DIATRAC GLYCOSYLATED HEMOGLOB, a Assay, Glycosylated Hemoglobin (Class II — Special Controls, product code LCP), submitted by Emd Chemicals, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 24, 1984, 47 days after receiving the submission on December 8, 1983. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7470.

Submission Details

510(k) Number K834294 FDA.gov
FDA Decision Cleared SESE
Date Received December 08, 1983
Decision Date January 24, 1984
Days to Decision 47 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

Product Code LCP — Assay, Glycosylated Hemoglobin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7470

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