Name: Predicase
Price: 199 USD

K-number	K004002
Device name	IMMULITE CK-MB, MODEL LKMB1 (100 TESTS), LKMB5 (500 TESTS); IMMULITE 2000 CK-MB, MODEL L2KMB2 (200 TESTS), L2KMB6 (600)
Applicant	Diagnostic Products Corp.
Product code	JHX
Device class	Class II
Decision date	Feb 14, 2001
Decision	Substantially Equivalent
Regulation	862.1215

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View the full FDA submission: accessdata.fda.gov

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IMMULITE CK-MB, MODEL LKMB1 (100 TESTS), LKMB5 (500 TESTS); IMMULITE 2000 CK-MB, MODEL L2KMB2 (200 TESTS), L2KMB6 (600)

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