I-STAT IONIZED CALCIUM TEST— 510(k) K934642

Substantially Equivalent

I-Stat Corp.

FDA 510(k) clearance K934642 for I-STAT IONIZED CALCIUM TEST, Substantially Equivalent on 1993-12-17. Applicant: I-Stat Corp.. Device class: 2.

Clearance details

Applicant: I-Stat Corp.
Product code: Code JFP
Device class: Class 2
Regulation: 21 CFR 862.1145
Advisory panel: Clinical Chemistry
Date received: 1993-09-21
Decision date: 1993-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Princeton, NJ, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.