FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
AmplideX Fragile X Dx & Carrier Screen Kit
K Number: DEN190023
·
Decision Feb 21, 2020
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
0
Applicant Total
3
Review Days
309
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Basic Information
- Device Name
- AmplideX Fragile X Dx & Carrier Screen Kit
- K Number
- DEN190023
- Device Class
- FDA class 2
- Clearance Type
- Direct
- Regulation Number
- 866.5970
- Medical Specialty
- Immunology
- Decision
- Unknown
- Applicant
- Asuragen, Inc.
- Date Received
- April 18, 2019
- Decision Date
- February 21, 2020
- Product Code
- OYV
- Advisory Committee
- Immunology
- Review Advisory Committee
- MG
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OYV | Inherited Nucleotide Repeat Disorder Dna Test | FDA class 2 | Immunology |