Cleared Traditional

FERRITIN CALIBRATOR

K963493 · Dade Chemistry Systems, Inc. · Chemistry
Dec 1996
Decision
91d
Days
Class 2
Risk

About This 510(k) Submission

K963493 is an FDA 510(k) clearance for the FERRITIN 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 December 3, 1996, 91 days after receiving the submission on September 3, 1996. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1150.

Submission Details

510(k) Number K963493 FDA.gov
FDA Decision Cleared SESE
Date Received September 03, 1996
Decision Date December 03, 1996
Days to Decision 91 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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