Name: Predicase
Price: 199 USD

K-number	K974461
Device name	TRIAGE CARDIAC CONTROLS, TRIAGE TROPONIN-I CONTROL, TRIAGE CK-MB CONTROL, TRIAGE MYOGLOBIN CONTROL
Applicant	Biosite Incorporated
Product code	JJT
Device class	Class I
Decision date	Dec 10, 1997
Decision	Substantially Equivalent
Regulation	862.1660

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Source

View the full FDA submission: accessdata.fda.gov

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TRIAGE CARDIAC CONTROLS, TRIAGE TROPONIN-I CONTROL, TRIAGE CK-MB CONTROL, TRIAGE MYOGLOBIN CONTROL

Everything you need for a 510(k) submission. Nothing you don't.