Name: Predicase
Price: 199 USD

K-number	K990377
Device name	ONTRAK TESTCUP M2K AND ONTRAK TESTSTIK POSITIVE CONTROL, MODEL 11 18544, ONTRAK TESTCUP M2K AND ONTRAK TESTSTICK NEGATIV
Applicant	Roche Diagnostics Corp.
Product code	DIF
Device class	Class I
Decision date	Feb 26, 1999
Decision	Substantially Equivalent
Regulation	862.3280

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Source

View the full FDA submission: accessdata.fda.gov

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ONTRAK TESTCUP M2K AND ONTRAK TESTSTIK POSITIVE CONTROL, MODEL 11 18544, ONTRAK TESTCUP M2K AND ONTRAK TESTSTICK NEGATIV

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