The following data is part of a premarket notification filed by Stanbio Laboratory with the FDA for Stanbio Laboratory Sirrus Clinical Chemistry Analyzer.
| Device ID | K042169 |
| 510k Number | K042169 |
| Device Name: | STANBIO LABORATORY SIRRUS CLINICAL CHEMISTRY ANALYZER |
| Classification | Analyzer, Chemistry (photometric, Discrete), For Clinical Use |
| Applicant | STANBIO LABORATORY 1261 NORTH MAIN ST. Boerne, TX 78006 |
| Contact | Kirk Johnson |
| Correspondent | Kirk Johnson STANBIO LABORATORY 1261 NORTH MAIN ST. Boerne, TX 78006 |
| Product Code | JJE |
| Subsequent Product Code | CDT |
| Subsequent Product Code | CGA |
| Subsequent Product Code | CHH |
| CFR Regulation Number | 862.2160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-08-11 |
| Decision Date | 2005-03-14 |
| Summary: | summary |