The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics with the FDA for Clinitek Novus; Automated Urine Chemistry Analyzer, 10 Urinalysis Cassette, Calibration Kit.
| Device ID | K140717 |
| 510k Number | K140717 |
| Device Name: | CLINITEK NOVUS; AUTOMATED URINE CHEMISTRY ANALYZER, 10 URINALYSIS CASSETTE, CALIBRATION KIT |
| Classification | Automated Urinalysis System |
| Applicant | SIEMENS HEALTHCARE DIAGNOSTICS 2 EDGEWATER DRIVE Norwood, MA 02062 |
| Contact | Susan Tibedo |
| Correspondent | Susan Tibedo SIEMENS HEALTHCARE DIAGNOSTICS 2 EDGEWATER DRIVE Norwood, MA 02062 |
| Product Code | KQO |
| Subsequent Product Code | CDM |
| Subsequent Product Code | CEN |
| Subsequent Product Code | JIL |
| Subsequent Product Code | JIN |
| Subsequent Product Code | JIO |
| Subsequent Product Code | JIR |
| Subsequent Product Code | JIX |
| Subsequent Product Code | JJB |
| Subsequent Product Code | JMT |
| Subsequent Product Code | JRE |
| Subsequent Product Code | LJX |
| CFR Regulation Number | 862.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-03-20 |
| Decision Date | 2014-11-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414981147 | K140717 | 000 |
| 00630414981130 | K140717 | 000 |
| 00630414602653 | K140717 | 000 |
| 00630414590950 | K140717 | 000 |
| 00630414590936 | K140717 | 000 |