Cleared Traditional

CIBA CORINING ACS THEOPHYLLINE IMMUNOASSAY

K951169 · Ciba Corning Diagnostics Corp. · Chemistry
Jun 1995
Decision
97d
Days
Class 2
Risk

About This 510(k) Submission

K951169 is an FDA 510(k) clearance for the CIBA CORINING ACS THEOPHYLLINE IMMUNOASSAY, a Fluorescence Polarization Immunoassay, Theophylline (Class II — Special Controls, product code LGS), submitted by Ciba Corning Diagnostics Corp. (Medfield, US). The FDA issued a Cleared decision on June 20, 1995, 97 days after receiving the submission on March 15, 1995. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3880.

Submission Details

510(k) Number K951169 FDA.gov
FDA Decision Cleared SESE
Date Received March 15, 1995
Decision Date June 20, 1995
Days to Decision 97 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code LGS — Fluorescence Polarization Immunoassay, Theophylline
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3880

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