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..

Clearance details

Applicant: I-Stat Corp.
Product code: Code CGL
Advisory panel: Clinical Chemistry
Date received: 1997-09-02
Decision date: 1997-10-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Princeton, NJ, US

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