510(k) DEN190023
- Device
- AmplideX Fragile X Dx & Carrier Screen Kit
- Applicant
- Asuragen, Inc.
- 510(k) number
- DEN190023
- Product code
- OYV
- Decision
- Unknown (DENG)
- Decision date
- 2020-02-21
- Date received
- 2019-04-18
- Regulation
- 866.5970
- Classification name
- Inherited Nucleotide Repeat Disorder Dna Test
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Bernard Andruss
- Address
- 2150 Woodward, Suite 100 Austin TX US 78744 78744
FDA Registration Numbers#
- 3003436513
Source Documents#
510(k) summary PDF not indicated by FDA