Cleared Traditional

DADE MONI-TROL CHEMISTRY CONTROL/CALIBRATOR

K871977 · American Dade · Chemistry
Jul 1987
Decision
48d
Days
Class 1
Risk

About This 510(k) Submission

K871977 is an FDA 510(k) clearance for the DADE MONI-TROL CHEMISTRY CONTROL/CALIBRATOR, a Multi-analyte Controls, All Kinds (assayed) (Class I — General Controls, product code JJY), submitted by American Dade (Santa Ana, US). The FDA issued a Cleared decision on July 9, 1987, 48 days after receiving the submission on May 22, 1987. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K871977 FDA.gov
FDA Decision Cleared SESE
Date Received May 22, 1987
Decision Date July 09, 1987
Days to Decision 48 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

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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