I-STAT LACTATE TEST— 510(k) K982071

Substantially Equivalent

I-Stat Corp.

FDA 510(k) clearance K982071 for I-STAT LACTATE TEST, Substantially Equivalent on 1998-06-29. Applicant: I-Stat Corp..

Clearance details

Applicant: I-Stat Corp.
Product code: Code KHP
Advisory panel: Clinical Chemistry
Date received: 1998-06-12
Decision date: 1998-06-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Princeton, NJ, US

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