Product code NAK— Clinical Chemistry
ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE KIT, 50 HOUR, PART NO. 80-8000-13K
- Classification name
- System, Test, Biotinidase
- Device class
- Class 2
- Regulation
- 21 CFR 862.1118
- Advisory panel
- Clinical Chemistry
- Total cleared
- 5
- First cleared
- Most recent
Market context for product code NAK
FDA has cleared devices under product code NAK between 2000 and 2013, filed by 4 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2013
- 2010
- 2008
- 2001
- 2000
Top applicants under product code NAK
Recent clearances under product code NAK
- K131284 — GSP NEONATAL BIOTINIDASE KIT
- K090123 — NEONATAL BIOTINIDASE KIT, MODEL 3018
- K080294 — ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE MICROPLATE REAGENT KIT
- K010844 — ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE KIT, 50 HOUR, PART NO. 80-8000-13K
- DEN990008 — WALLAC NEONATAL BIOTINIDASE TEST KIT, MODELS NB-1000; NB-4000
Data sourced from openFDA. This site is unofficial and independent of the FDA.