I-STAT SYSTEM— 510(k) K973292

Substantially Equivalent

I-Stat Corp.

FDA 510(k) clearance K973292 for I-STAT SYSTEM, Substantially Equivalent on 1997-10-20. Applicant: I-Stat Corp.. Device class: 2.

Clearance details

Applicant: I-Stat Corp.
Product code: Product code CGL
Device class: Class 2
Regulation: 21 CFR 862.1225
Advisory panel: Clinical Chemistry
Date received: 1997-09-02
Decision date: 1997-10-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Princeton, NJ, US

Download summary PDF View on FDA.gov ↗

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