Name: Predicase
Price: 199 USD

K-number	K170652
Device name	ARCHITECT B.R.A.H.M.S PCT, ARCHITECT B.R.A.H.M.S PCT Calibrators, ARCHITECT B.R.A.H.M.S PCT Controls
Applicant	Fisher Diagnostics
Product code	PRI
Device class	Class II
Decision date	Jun 1, 2017
Decision	Substantially Equivalent
Regulation	866.3215

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Source

View the full FDA submission: accessdata.fda.gov

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ARCHITECT B.R.A.H.M.S PCT, ARCHITECT B.R.A.H.M.S PCT Calibrators, ARCHITECT B.R.A.H.M.S PCT Controls

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