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Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name
assayed external control material for microbiology nucleic acid amplification (nat) assays
De Novo 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
Requester
bio-rad laboratories
9500 jeronimo road
irvine, CA 92614
Contact
elizabeth platt
Regulation Number
866.3920
Classification Product Code
PMN
Date Received
12/16/2015
Decision Date
03/28/2016
Decision
granted (DENG)
Classification Advisory Committee
Microbiology
Review Advisory Committee
Microbiology
Classification Order
Classification Order
FDA Review
Decision Summary
Type
Post-NSE
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