AmplideX Fragile X Dx & Carrier Screen Kit
FDA 510(k) clearance DEN190023 · decided 2020-02-21
Clearance details
- K-number
- DEN190023
- Device name
- AmplideX Fragile X Dx & Carrier Screen Kit
- Applicant
- Asuragen, Inc.
- Decision
- Unknown
- Date received
- 2019-04-18
- Decision date
- 2020-02-21
- Days to decision
- 309 days
- Clearance type
- Direct
- Product code
- OYV
- Device class
- 2
- Regulation number
- 866.5970
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Austin, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.