Cleared Traditional

I-STAT IONIZED CALCIUM TEST

K934642 · I-Stat Corp. · Chemistry
Dec 1993
Decision
87d
Days
Class 2
Risk

About This 510(k) Submission

K934642 is an FDA 510(k) clearance for the I-STAT IONIZED CALCIUM TEST, a Electrode, Ion Specific, Calcium (Class II — Special Controls, product code JFP), submitted by I-Stat Corp. (Princeton, US). The FDA issued a Cleared decision on December 17, 1993, 87 days after receiving the submission on September 21, 1993. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1145.

Submission Details

510(k) Number K934642 FDA.gov
FDA Decision Cleared SESE
Date Received September 21, 1993
Decision Date December 17, 1993
Days to Decision 87 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JFP — Electrode, Ion Specific, Calcium
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1145

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