I-STAT(TM) LEVELS 1,2,3 CONTROLS— 510(k) K921477

Substantially Equivalent

I-Stat Corp.

FDA 510(k) clearance K921477 for I-STAT(TM) LEVELS 1,2,3 CONTROLS, Substantially Equivalent on 1992-11-02. Applicant: I-Stat Corp..

Clearance details

Applicant: I-Stat Corp.
Product code: Code JJY
Advisory panel: Clinical Chemistry
Date received: 1992-03-30
Decision date: 1992-11-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ontario K2l 1t9, Canada, CA

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