Device product
AMS BUN UREA NITROGEN For the In vitro quantitative determination of Urea Nitrogen in serum Quantitative determination of Bun in serum.
Z-1267-2014
Product summary
- Event
- Event 67599
- Status
- Terminated
- Classification
- Class II
- Quantity
- 167 kits
- Official record key
device-enforcement:Z-1267-2014
Official wording
Reason: Marketing the devices outside 510(k) requirements
Code information: Model Numbers: 40072, 40146, 81046. Lot codes: 131083, 131084, 131085, 131086, 131087, 131088, 131089, 1310810, 1310811, 1310812, 1310813, 1310814, 1310815, 141081.
Distribution pattern: Nationwide Distribution including FL, GA, MD, CA, NC, MA, SC, WY, and TX.
Derived failure modes
-
Unknown
Marketing the devices outside 510(k) requirements