Name: Predicase
Price: 199 USD

K-number	K022118
Device name	IMMULITE TURBO CK-MB, MODELS LSKCP1 (100 TESTS), LSKCP5 (500 TESTS)
Applicant	Diagnostic Products Corp.
Product code	JHX
Device class	Class II
Decision date	Jul 22, 2002
Decision	Substantially Equivalent
Regulation	862.1215

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Source

View the full FDA submission: accessdata.fda.gov

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IMMULITE TURBO CK-MB, MODELS LSKCP1 (100 TESTS), LSKCP5 (500 TESTS)

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