Accula Strep A Test— 510(k) K201269
Substantially EquivalentMesa Biotech, Inc.
FDA 510(k) clearance K201269 for Accula Strep A Test, Substantially Equivalent on 2020-11-09. Applicant: Mesa Biotech, Inc.. Device class: 2.
Clearance details
- Applicant
- Mesa Biotech, Inc.
- 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
- San Diego, CA, US
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