Cleared Traditional

SAITRON 430 RANDOM ACCESS CHEMISTRY ANALYZER

K884035 · Sclavo, Inc. · Chemistry
Dec 1988
Decision
97d
Days
Class 1
Risk

About This 510(k) Submission

K884035 is an FDA 510(k) clearance for the SAITRON 430 RANDOM ACCESS CHEMISTRY ANALYZER, a Analyzer, Chemistry (photometric, Discrete), For Clinical Use (Class I — General Controls, product code JJE), submitted by Sclavo, Inc. (Wayne, US). The FDA issued a Cleared decision on December 29, 1988, 97 days after receiving the submission on September 23, 1988. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2160.

Submission Details

510(k) Number K884035 FDA.gov
FDA Decision Cleared SESE
Date Received September 23, 1988
Decision Date December 29, 1988
Days to Decision 97 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code JJE — Analyzer, Chemistry (photometric, Discrete), For Clinical Use
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.2160

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