The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics with the FDA for Clinitek Status+analyzer And Clinitek Status Connect System, Models 1780, 1797.
| Device ID | K091216 |
| 510k Number | K091216 |
| Device Name: | CLINITEK STATUS+ANALYZER AND CLINITEK STATUS CONNECT SYSTEM, MODELS 1780, 1797 |
| Classification | Method, Enzymatic, Glucose (urinary, Non-quantitative) |
| Applicant | SIEMENS HEALTHCARE DIAGNOSTICS 2 EDGEWATER DRIVE Norwood, MA 02062 |
| Contact | Noor Malki |
| Correspondent | Noor Malki SIEMENS HEALTHCARE DIAGNOSTICS 2 EDGEWATER DRIVE Norwood, MA 02062 |
| Product Code | JIL |
| Subsequent Product Code | CDM |
| Subsequent Product Code | CEN |
| Subsequent Product Code | JFY |
| Subsequent Product Code | JHI |
| Subsequent Product Code | JIN |
| Subsequent Product Code | JIP |
| Subsequent Product Code | JIR |
| Subsequent Product Code | JJB |
| Subsequent Product Code | JMT |
| Subsequent Product Code | JRE |
| Subsequent Product Code | KQO |
| Subsequent Product Code | LJX |
| CFR Regulation Number | 862.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-27 |
| Decision Date | 2009-10-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414578330 | K091216 | 000 |
| 00630414574639 | K091216 | 000 |
| 00630414572314 | K091216 | 000 |
| 00630414571263 | K091216 | 000 |
| 00630414607962 | K091216 | 000 |