Cleared Traditional

ACA PLUS FERRITIN CALIBRATOR

K935543 · E.I. Dupont DE Nemours & Co., Inc. · Chemistry
Mar 1994
Decision
126d
Days
Class 2
Risk

About This 510(k) Submission

K935543 is an FDA 510(k) clearance for the ACA PLUS FERRITIN CALIBRATOR, a Calibrator, Multi-analyte Mixture (Class II — Special Controls, product code JIX), submitted by E.I. Dupont DE Nemours & Co., Inc. (Wilmington, US). The FDA issued a Cleared decision on March 22, 1994, 126 days after receiving the submission on November 16, 1993. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1150.

Submission Details

510(k) Number K935543 FDA.gov
FDA Decision Cleared SESE
Date Received November 16, 1993
Decision Date March 22, 1994
Days to Decision 126 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JIX — Calibrator, Multi-analyte Mixture
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1150

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