510(k) K202755
- Device
- Simplexa Congenital CMV Direct And Simplexa Congenital CMV Positive Control Pack
- Applicant
- DiaSorin Molecular LLC
- 510(k) number
- K202755
- Product code
- QDZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-11-05
- Date received
- 2020-09-21
- Regulation
- 866.3181
- Classification name
- Qualitative Cytomegalovirus Nucleic Acid-based Detection Device For Congenital Cytomegalovirus Infection
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Sharon Young
- Address
- 11331 Valley View St. Cypress CA US 90630 90630
FDA Registration Numbers#
- 2023365
- 1524213
- 2022994
Source Documents#
Other 510(k) Records For Product Code QDZ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| DEN180040 | Alethia CMV DNA Amplification Assay, Alethia CMV External Control Kit | Meridian Bioscience, Inc. | 2018-11-30 |
Legacy Summary#
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FDA Review#
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