Device product
AMS URIC ACID For the In vitro quantitative determination of Uric Acid in serum Quantitative determination of Uric Acid in serum.
Z-1268-2014
Product summary
- Event
- Event 67599
- Status
- Terminated
- Classification
- Class II
- Quantity
- 13 kits
- Official record key
device-enforcement:Z-1268-2014
Official wording
Reason: Marketing the devices outside 510(k) requirements
Code information: Model Numbers: 40147, 80147. Lot codes: 131253, 131254, 131255.
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