Name: Predicase
Price: 199 USD

K-number	K011505
Device name	IMMULITE INTACT PTH, MODEL LKPP1 (100 TESTS), LKPP5 (500 TESTS), IMMULITE 2000 INTACT PTH, MODEL L2KPP (200 TESTS), L2K6
Applicant	Diagnostic Products Corp.
Product code	CEW
Device class	Class II
Decision date	Jul 2, 2001
Decision	Substantially Equivalent
Regulation	862.1545

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Source

View the full FDA submission: accessdata.fda.gov

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IMMULITE INTACT PTH, MODEL LKPP1 (100 TESTS), LKPP5 (500 TESTS), IMMULITE 2000 INTACT PTH, MODEL L2KPP (200 TESTS), L2K6

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