Cleared Traditional

CIBA CORNING MODEL 644

K875098 · Ciba Corning Diagnostics Corp. · Chemistry
Mar 1988
Decision
84d
Days
Class 1
Risk

About This 510(k) Submission

K875098 is an FDA 510(k) clearance for the CIBA CORNING MODEL 644, a Atomic Absorption Spectrophotometer, General Use (Class I — General Controls, product code JXR), submitted by Ciba Corning Diagnostics Corp. (East Walpole, US). The FDA issued a Cleared decision on March 3, 1988, 84 days after receiving the submission on December 10, 1987. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2850.

Submission Details

510(k) Number K875098 FDA.gov
FDA Decision Cleared SESE
Date Received December 10, 1987
Decision Date March 03, 1988
Days to Decision 84 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code JXR — Atomic Absorption Spectrophotometer, General Use
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.2850

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