Cleared Traditional

ACE(TM) CLIN CHEM SYST W/OPT ION SELECT ELECTR(ISE)

K933862 · Schiapparelli Biosystems, Inc. · Chemistry
Oct 1993
Decision
64d
Days
Class 2
Risk

About This 510(k) Submission

K933862 is an FDA 510(k) clearance for the ACE(TM) CLIN CHEM SYST W/OPT ION SELECT ELECTR(ISE), a Electrode, Ion Specific, Sodium (Class II — Special Controls, product code JGS), submitted by Schiapparelli Biosystems, Inc. (Columbia, US). The FDA issued a Cleared decision on October 12, 1993, 64 days after receiving the submission on August 9, 1993. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1665.

Submission Details

510(k) Number K933862 FDA.gov
FDA Decision Cleared SESE
Date Received August 09, 1993
Decision Date October 12, 1993
Days to Decision 64 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JGS — Electrode, Ion Specific, Sodium
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1665

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