The following data is part of a premarket notification filed by Stanbio Laboratory with the FDA for Creatinine Liquicolor.
| Device ID | K050283 |
| 510k Number | K050283 |
| Device Name: | CREATININE LIQUICOLOR |
| Classification | Enzymatic Method, Creatinine |
| 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 | JFY |
| CFR Regulation Number | 862.1225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-02-07 |
| Decision Date | 2005-06-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811727014733 | K050283 | 000 |
| 00811727014726 | K050283 | 000 |
| 00811727014498 | K050283 | 000 |
| 00811727014481 | K050283 | 000 |
| 00811727014474 | K050283 | 000 |
| 00811727013507 | K050283 | 000 |
| 00811727016072 | K050283 | 000 |