Name: Predicase
Price: 199 USD

K-number	K141907
Device name	STAT PROFILE PRIME CCS ANALYZER SYSTEM, STAT PROFILE PRIME AUTO QC CARTRIDGE CCS, STAT PROFILE PRIME AMPULED CONTROL ABG/CCS, STAT PROFILE PRIME CALIBRTOR CARTRIDGE CCS/CCS COMP, NOVA LINEARITY STANDARD SET A
Applicant	Nova Biomedical Corporation
Product code	CHL
Device class	Class II
Decision date	May 29, 2015
Decision	Substantially Equivalent
Regulation	862.1120

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Source

View the full FDA submission: accessdata.fda.gov

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STAT PROFILE PRIME CCS ANALYZER SYSTEM, STAT PROFILE PRIME AUTO QC CARTRIDGE CCS, STAT PROFILE PRIME AMPULED CONTROL ABG/CCS, STAT PROFILE PRIME CALIBRTOR CARTRIDGE CCS/CCS COMP, NOVA LINEARITY STANDARD SET A

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