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510(k) Data Aggregation
K Number
K112430Device Name
I-STAT LACTATE TEST/I-SAT CG4+CARTRIDGE
Manufacturer
ABBOTT PONT OF CARE INC
Date Cleared
2011-12-20
(118 days)
Product Code
KHP, DAT
Regulation Number
862.1450Why did this record match?
Applicant Name (Manufacturer) :
ABBOTT PONT OF CARE INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Lactate Acid Test is indicated for (1) the diagnosis and treatment of lactic acidosis in conjunction with measurements of blood acid/base status, (2) monitoring tissue hypoxia and strenuous physical exertion, (3) diagnosis of hyperlactatemia.
The Lactate Test, as part of the i-STAT System, is intended for the in vitro measurement of lactate in arterial, venous, or capillary whole blood.
Device Description
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