Xpert Xpress Strep A— 510(k) K173398
Substantially EquivalentCepheid
FDA 510(k) clearance K173398 for Xpert Xpress Strep A, Substantially Equivalent on 2018-04-26. Applicant: Cepheid. Device class: 2.
Clearance details
- Applicant
- Cepheid
- Product code
- Code PGX
- Device class
- Class 2
- Regulation
- 21 CFR 866.2680
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Dual Track
- Location
- Sunnyvale, CA, US
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More clearances from Cepheid
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