Elecsys Syphilis— 510(k) K160910
Substantially EquivalentRoche Diagnostics
FDA 510(k) clearance K160910 for Elecsys Syphilis, Substantially Equivalent on 2016-07-28. Applicant: Roche Diagnostics. Device class: 2.
Clearance details
- Applicant
- Roche Diagnostics
- Product code
- Code LIP
- Device class
- Class 2
- Regulation
- 21 CFR 866.3830
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Indianapolis, IN, US
Recent devices under product code LIP
view all- K241427 — Access Syphilis
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- K211302 — Elecsys Syphilis
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- K153145 — Lumipulse G TP-N Immunoreaction Cartridge Set
More clearances from Roche Diagnostics
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