Name: Predicase
Price: 199 USD

K-number	K974839
Device name	ALPHA DX ANALYZER 01-0100, ALPHA DX MYO/CK/CK-MB/TNI CARDIAC PANEL TEST KIT 03-0001, ALPHA DX CK/CK-MB PANEL TEST KIT
Applicant	First Medical, Inc.
Product code	MMI
Device class	Class II
Decision date	Feb 4, 1998
Decision	Substantially Equivalent
Regulation	862.1215

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Source

View the full FDA submission: accessdata.fda.gov

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ALPHA DX ANALYZER 01-0100, ALPHA DX MYO/CK/CK-MB/TNI CARDIAC PANEL TEST KIT 03-0001, ALPHA DX CK/CK-MB PANEL TEST KIT

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