FDA-Device2014-05-14Class III

CLINITEK Status+ Analyzer (portable urine chemistry analyzer). Catalog number 10490946.

Siemens Healthcare Diagnostics Inc
Hazard

Device with Sample Interference Notes (SIN) enabled not cleared for US marketing.

Sold states
US Distribution in the state of: CA.
Affected count
1 unit
Manufactured in
2 Edgewater Drive, N/A, Norwood, MA, United States
Products
CLINITEK Status+ Analyzer (portable urine chemistry analyzer). Catalog number 10490946.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1545-2014

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