K-number	K221605
Device name	Emit® II Plus Buprenorphine Assay
Applicant	Siemens Healthcare Diagnostics, Inc.
Product code	DJG
Device class	Class II
Decision date	Jul 25, 2023
Decision	Substantially Equivalent
Regulation	862.3650

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Source

View the full FDA submission: accessdata.fda.gov

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Emit® II Plus Buprenorphine Assay

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