Simplexa VZV Direct, Simplexa VZV Positive Control Pack
FDA 510(k) clearance K190219 · decided 2019-05-13
Clearance details
- K-number
- K190219
- Device name
- Simplexa VZV Direct, Simplexa VZV Positive Control Pack
- Applicant
- Diasorin Molecular, LLC
- Decision
- Substantially Equivalent
- Date received
- 2019-02-04
- Decision date
- 2019-05-13
- Days to decision
- 98 days
- Clearance type
- Traditional
- Product code
- PLO
- Device class
- 2
- Regulation number
- 866.3970
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Cypress, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| MOL3650 Simplexa VZV Direct - Product Usage: is intended for use on the LIAISON MDX instru recall (Z-2548-2020) | DiaSorin Molecular LLC | 2020-07-10 |