510(k) K091216 ยท JIL Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
CLINITEK STATUS+ANALYZER AND CLINITEK STATUS CONNECT SYSTEM, MODELS 1780, 1797
| Applicant | Siemens Healthcare Diagnostics, Norowood MA, US |
| Decision | Substantially Equivalent, Oct 9, 2009 |
| Received | Apr 27, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K091216
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 17, 2014 | Siemens Healthcare Diagnostics, Inc External power supply adaptors that accompany Clinitek Status+
The Clinitek Status systems is a urine analyzer. Terminated |
JIL | None listed |
| Oct 17, 2014 | Siemens Healthcare Diagnostics, Inc External power supply adaptors that accompany Clinitek Status Connect System
The Clinitek Status system is a urine analyzer. Terminated |
JIL | None listed |
| Oct 17, 2014 | Siemens Healthcare Diagnostics, Inc External power supply adaptors that accompany Clinitek Status Power Supply Adaptor - Spare Part
The Clinitek Status system is a urine analyzer. Terminated |
JIL | None listed |
| May 4, 2014 | Siemens Healthcare Diagnostics Inc CLINITEK Status+ Analyzer (portable urine chemistry analyzer). Catalog number 10490946. Terminated |
KQO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.