Device product
CLINITEK Status+ Analyzer (portable urine chemistry analyzer). Catalog number 10490946.
Z-1545-2014
Product summary
- Event
- Event 67930
- Status
- Terminated
- Classification
- Class III
- Quantity
- 1 unit
- Official record key
device-enforcement:Z-1545-2014
Official wording
Reason: Device with Sample Interference Notes (SIN) enabled not cleared for US marketing.
Code information: Serial Number: 212809
Distribution pattern: US Distribution in the state of: CA.
Derived failure modes
-
Unknown
Device with Sample Interference Notes (SIN) enabled not cleared for US marketing.