Name: Predicase
Price: 199 USD

K-number	DEN150058
Device name	Amplichek II, Negative and Amplichek II, Negative MiniPak, Amplichek II, Level 1 and Amplichek II, Level 1 MiniPak, Amplichek II, Level 2 and Amplichek II, Level 2 MiniPak, Amplichek II, Level 3 and Amplichek II, Level 3 MiniPak
Applicant	Bio-Rad Laboratories
Product code	PMN
Device class	Class II
Decision date	Mar 28, 2016
Decision	Not Substantially Equivalent
Regulation	866.3920

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Source

View the full FDA submission: accessdata.fda.gov

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Amplichek II, Negative and Amplichek II, Negative MiniPak, Amplichek II, Level 1 and Amplichek II, Level 1 MiniPak, Amplichek II, Level 2 and Amplichek II, Level 2 MiniPak, Amplichek II, Level 3 and Amplichek II, Level 3 MiniPak

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