Cleared Traditional

DUPONT ACA(R) PLUS IMMUNOASSAY SYS FERRITIN(FERR) METH

K935528 · E.I. Dupont DE Nemours & Co., Inc. · Immunology
Jan 1994
Decision
73d
Days
Class 2
Risk

About This 510(k) Submission

K935528 is an FDA 510(k) clearance for the DUPONT ACA(R) PLUS IMMUNOASSAY SYS FERRITIN(FERR) METH, a Ferritin, Antigen, Antiserum, Control (Class II — Special Controls, product code DBF), submitted by E.I. Dupont DE Nemours & Co., Inc. (Wilmington, US). The FDA issued a Cleared decision on January 28, 1994, 73 days after receiving the submission on November 16, 1993. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5340.

Submission Details

510(k) Number K935528 FDA.gov
FDA Decision Cleared SESE
Date Received November 16, 1993
Decision Date January 28, 1994
Days to Decision 73 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code DBF — Ferritin, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5340

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