Name: Predicase
Price: 199 USD

K-number	K171771
Device name	ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) Assay
Applicant	Siemens Healthcare Diagnostics, Inc.
Product code	PDJ
Device class	Class II
Decision date	Dec 4, 2017
Decision	Substantially Equivalent
Regulation	862.1373

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Source

View the full FDA submission: accessdata.fda.gov

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ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) Assay

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