Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack
FDA 510(k) clearance K202755 · decided 2022-11-05
Clearance details
- K-number
- K202755
- Device name
- Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack
- Applicant
- Diasorin Molecular, LLC
- Decision
- Substantially Equivalent
- Date received
- 2020-09-21
- Decision date
- 2022-11-05
- Days to decision
- 775 days
- Clearance type
- Traditional
- Product code
- QDZ
- Device class
- 2
- Regulation number
- 866.3181
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Cypress, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Alethia CMV DNA Amplification Assay, Alethia CMV External Control Kit (DEN180040) | Meridian Bioscience, Inc. | 2018-11-30 |
Recalls involving this device
No recalls on record reference this clearance.