K-number	K151578
Device name	Carbamazepine Gen 4
Applicant	Roche Diagnostics Operations (Rdo)
Product code	KLT
Device class	Class II
Decision date	Oct 22, 2015
Decision	Substantially Equivalent
Regulation	862.3645

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Source

View the full FDA submission: accessdata.fda.gov

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Carbamazepine Gen 4

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