Name: Predicase
Price: 199 USD

K-number	K081008
Device name	BUPRENORPHINE ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS FOR BECKMAN COULTER SYNCHRON SYSTEMS
Applicant	Lin-Zhi International, Inc.
Product code	DJG
Device class	Class II
Decision date	Dec 22, 2008
Decision	Substantially Equivalent
Regulation	862.3650

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Source

View the full FDA submission: accessdata.fda.gov

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BUPRENORPHINE ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS FOR BECKMAN COULTER SYNCHRON SYSTEMS

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