Cleared Traditional

DADE ANEMIA/HEMOCHROMATOSIS CONTOLS,LEVEL 1,LEVEL 2,AND LEVEL 3

K933437 · Baxter Diagnostics, Inc. · Chemistry
Oct 1993
Decision
106d
Days
Class 1
Risk

About This 510(k) Submission

K933437 is an FDA 510(k) clearance for the DADE ANEMIA/HEMOCHROMATOSIS CONTOLS,LEVEL 1,LEVEL 2,AND LEVEL 3, a Multi-analyte Controls, All Kinds (assayed) (Class I — General Controls, product code JJY), submitted by Baxter Diagnostics, Inc. (Miami, US). The FDA issued a Cleared decision on October 28, 1993, 106 days after receiving the submission on July 14, 1993. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K933437 FDA.gov
FDA Decision Cleared SESE
Date Received July 14, 1993
Decision Date October 28, 1993
Days to Decision 106 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JJY — Multi-analyte Controls, All Kinds (assayed)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1660

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