NAK — System, Test, Biotinidase Class II
FDA Device Classification
Classification Details
- Product Code
- NAK
- Device Class
- Class II
- Regulation Number
- 862.1118
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K131284 | wallac | GSP NEONATAL BIOTINIDASE KIT | November 14, 2013 |
| K090123 | perkinelmer | NEONATAL BIOTINIDASE KIT, MODEL 3018 | March 5, 2010 |
| K080294 | astoria-pacific | ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE MICROPLATE REAGENT KIT | November 4, 2008 |
| K010844 | astoria-pacific | ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE KIT, 50 HOUR, PART NO. 80-8000-13K | September 21, 2001 |
| DEN990008 | wallac | WALLAC NEONATAL BIOTINIDASE TEST KIT, MODELS NB-1000; NB-4000 | February 15, 2000 |