Name: Predicase
Price: 199 USD

K-number	K160647
Device name	IMMULITE 2000 Third Generation TSH, IMMULITE 2000 Free T4
Applicant	Siemens Healthcare Diagnostics, Inc.
Product code	JLW
Device class	Class II
Decision date	May 31, 2016
Decision	Substantially Equivalent
Regulation	862.1690

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Source

View the full FDA submission: accessdata.fda.gov

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IMMULITE 2000 Third Generation TSH, IMMULITE 2000 Free T4

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