FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
SEEKER System
K Number: DEN150035
·
Decision Feb 3, 2017
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
2
Applicant Total
3
Review Days
548
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Basic Information
- Device Name
- SEEKER System
- K Number
- DEN150035
- Device Class
- FDA class 2
- Clearance Type
- Direct
- Regulation Number
- 862.1488
- Medical Specialty
- Clinical Chemistry
- Decision
- Unknown
- Applicant
- Baebies, Inc.
- Date Received
- August 5, 2015
- Decision Date
- February 3, 2017
- Product Code
- PQW
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| PQW | Alpha-D-Galactosidase A (Gla) Newborn Screening Test System | FDA class 2 | Clinical Chemistry |
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