Name: Predicase
Price: 199 USD

K-number	K110571
Device name	TELCARE BLOOD GLUCOSE MONITORING SYSTEM, TEST STRIPS, CONTROL SOLUTIONS, TELSERVE-HOME USE, TELSERVE-PROFESSIONAL USE
Applicant	Telcare, Inc.
Product code	NBW
Device class	Class II
Decision date	Jul 28, 2011
Decision	Substantially Equivalent
Regulation	862.1345

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Source

View the full FDA submission: accessdata.fda.gov

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TELCARE BLOOD GLUCOSE MONITORING SYSTEM, TEST STRIPS, CONTROL SOLUTIONS, TELSERVE-HOME USE, TELSERVE-PROFESSIONAL USE

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