FREND PSA PLUS (reagent cartridge)— 510(k) K162378
Substantially EquivalentNanoentek USA, Inc.
FDA 510(k) clearance K162378 for FREND PSA PLUS (reagent cartridge), Substantially Equivalent on 2017-05-17. Applicant: Nanoentek USA, Inc.. Device class: 2.
Clearance details
- Applicant
- Nanoentek USA, Inc.
- Product code
- Code LTJ
- Device class
- Class 2
- Regulation
- 21 CFR 866.6010
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Pleasanton, CA, US
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More clearances from Nanoentek USA, Inc.
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