Name: Predicase
Price: 199 USD

K-number	K981493
Device name	MTM BIOSCANNER C TEST STRIPS MODEL NUMBER BSA 200, BSA 210, BSA 220
Applicant	Polymer Technology Systems, Inc.
Product code	CHH
Device class	Class I
Decision date	Jul 22, 1998
Decision	Substantially Equivalent
Regulation	862.1175

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Source

View the full FDA submission: accessdata.fda.gov

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MTM BIOSCANNER C TEST STRIPS MODEL NUMBER BSA 200, BSA 210, BSA 220

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