Cleared Traditional

CIBA CORNING ACS;180 DPD ASSAY

K963251 · Ciba Corning Diagnostics Corp. · Chemistry
Oct 1996
Decision
57d
Days
Class 1
Risk

About This 510(k) Submission

K963251 is an FDA 510(k) clearance for the CIBA CORNING ACS;180 DPD ASSAY, a Column Chromatography & Color Development, Hydroxyproline (Class I — General Controls, product code JMM), submitted by Ciba Corning Diagnostics Corp. (Irvine, US). The FDA issued a Cleared decision on October 15, 1996, 57 days after receiving the submission on August 19, 1996. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1400.

Submission Details

510(k) Number K963251 FDA.gov
FDA Decision Cleared SESE
Date Received August 19, 1996
Decision Date October 15, 1996
Days to Decision 57 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JMM — Column Chromatography & Color Development, Hydroxyproline
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1400

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