I-STAT CONTROL LEVELS 1,2,3— 510(k) K934641

Substantially Equivalent

I-Stat Corp.

FDA 510(k) clearance K934641 for I-STAT CONTROL LEVELS 1,2,3, Substantially Equivalent on 1993-12-09. Applicant: I-Stat Corp.. Device class: 1.

Clearance details

Applicant: I-Stat Corp.
Product code: Code JJR
Device class: Class 1
Regulation: 21 CFR 862.1660
Advisory panel: Clinical Chemistry
Date received: 1993-09-21
Decision date: 1993-12-09
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.