Name: Predicase
Price: 199 USD

K-number	K122534
Device name	IMMULITE 1000 THIRD GENERATION PSA CALIBRATION VERIFICATION MATERIAL
Applicant	Siemens Healthcare Diagnostics, Inc.
Product code	JJX
Device class	Class I
Decision date	Mar 14, 2013
Decision	Substantially Equivalent
Regulation	862.1660

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Source

View the full FDA submission: accessdata.fda.gov

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IMMULITE 1000 THIRD GENERATION PSA CALIBRATION VERIFICATION MATERIAL

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