Cleared Traditional

MODIFIED MODEL 570 CLINICAL CHEMISTRY ANALYZER

K893838 · Ciba Corning Diagnostics Corp. · Chemistry
Aug 1989
Decision
99d
Days
Class 1
Risk

About This 510(k) Submission

K893838 is an FDA 510(k) clearance for the MODIFIED MODEL 570 CLINICAL CHEMISTRY ANALYZER, a Calculator/data Processing Module, For Clinical Use (Class I — General Controls, product code JQP), submitted by Ciba Corning Diagnostics Corp. (East Walpole, US). The FDA issued a Cleared decision on August 31, 1989, 99 days after receiving the submission on May 24, 1989. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2100.

Submission Details

510(k) Number K893838 FDA.gov
FDA Decision Cleared SESE
Date Received May 24, 1989
Decision Date August 31, 1989
Days to Decision 99 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code JQP — Calculator/data Processing Module, For Clinical Use
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.2100

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