Cleared Traditional

MMB CALIBRATOR

K970336 · Dade Chemistry Systems, Inc. · Chemistry
Mar 1997
Decision
33d
Days
Class 2
Risk

About This 510(k) Submission

K970336 is an FDA 510(k) clearance for the MMB CALIBRATOR, a Calibrator, Secondary (Class II — Special Controls, product code JIT), submitted by Dade Chemistry Systems, Inc. (Newark, US). The FDA issued a Cleared decision on March 3, 1997, 33 days after receiving the submission on January 29, 1997. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1150.

Submission Details

510(k) Number K970336 FDA.gov
FDA Decision Cleared SESE
Date Received January 29, 1997
Decision Date March 03, 1997
Days to Decision 33 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JIT — Calibrator, Secondary
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1150

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