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— 510(k) DEN150058
UnknownBio-Rad Laboratories
FDA 510(k) clearance DEN150058 for 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, Unknown on 2016-03-28. Applicant: Bio-Rad Laboratories. Device class: 2.
Clearance details
- Applicant
- Bio-Rad Laboratories
- Product code
- Code PMN
- Device class
- Class 2
- Regulation
- 21 CFR 866.3920
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Post-NSE
- Location
- Irvine, CA, US
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