I-STAT SYSTEM— 510(k) K011478

Substantially Equivalent

I-Stat Corp.

FDA 510(k) clearance K011478 for I-STAT SYSTEM, Substantially Equivalent on 2001-07-02. Applicant: I-Stat Corp..

Clearance details

Applicant: I-Stat Corp.
Product code: Code KHP
Advisory panel: Clinical Chemistry
Date received: 2001-05-14
Decision date: 2001-07-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: East Windsor, NJ, US

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