K112430

Substantially Equivalent

I-STAT LACTATE TEST/I-SAT CG4+CARTRIDGE

Applicant: Abbott Pont of Care, Inc.
Product code: KHP
Advisory panel: Clinical Chemistry
Date received: 2011-08-24
Decision date: 2011-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Princton, NJ, US

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