Cleared Traditional

CHIRON DIAGNOSTICS ACS: 180 FOLATE

K991582 · Chiron Diagnostics Corp. · Immunology
Jun 1999
Decision
54d
Days
Class 2
Risk

About This 510(k) Submission

K991582 is an FDA 510(k) clearance for the CHIRON DIAGNOSTICS ACS: 180 FOLATE, a Acid, Folic, Radioimmunoassay (Class II — Special Controls, product code CGN), submitted by Chiron Diagnostics Corp. (Medfield, US). The FDA issued a Cleared decision on June 30, 1999, 54 days after receiving the submission on May 7, 1999. This device falls under the Immunology review panel. Regulated under 21 CFR 862.1295.

Submission Details

510(k) Number K991582 FDA.gov
FDA Decision Cleared SESE
Date Received May 07, 1999
Decision Date June 30, 1999
Days to Decision 54 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code CGN — Acid, Folic, Radioimmunoassay
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1295

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