GSP NEONATAL BIOTINIDASE KIT— 510(k) K131284
Substantially EquivalentWallac OY
FDA 510(k) clearance K131284 for GSP NEONATAL BIOTINIDASE KIT, Substantially Equivalent on 2013-11-14. Applicant: Wallac OY. Device class: 2.
Clearance details
- Applicant
- Wallac OY
- Product code
- Code NAK
- Device class
- Class 2
- Regulation
- 21 CFR 862.1118
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Waltham, MA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.