← FDA Medical Device Classifications
Alpha-D-Glucosidase (Gaa) Newborn Screening Test System
PQU · Class II — Moderate Risk (510(k) clearance required) · Clinical Chemistry · 21 CFR 862.1488
Classification
- FDA Product Code
PQU- Device class
- Class II — Moderate Risk (510(k) clearance required)
- Regulation
- 21 CFR 862.1488
- Review panel
- CH
- Medical specialty
- Clinical Chemistry
- Submission type
- 1
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- Y
Definition
For quantitative measurement of the activity of alpha-D-glucosidase (GAA) from newborn dried blood spot specimens.
Market data
- Cleared 510(k) submissions
- 0
- Registered establishments
- 3
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown