Cleared Traditional

CHIRON DIAGNOSTICS ACS: 180 FERRITIN ASSAY

K992157 · Chiron Diagnostics Corp. · Immunology
Aug 1999
Decision
41d
Days
Class 2
Risk

About This 510(k) Submission

K992157 is an FDA 510(k) clearance for the CHIRON DIAGNOSTICS ACS: 180 FERRITIN ASSAY, a Ferritin, Antigen, Antiserum, Control (Class II — Special Controls, product code DBF), submitted by Chiron Diagnostics Corp. (Medfield, US). The FDA issued a Cleared decision on August 5, 1999, 41 days after receiving the submission on June 25, 1999. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5340.

Submission Details

510(k) Number K992157 FDA.gov
FDA Decision Cleared SESE
Date Received June 25, 1999
Decision Date August 05, 1999
Days to Decision 41 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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