The following data is part of a premarket notification filed by Stanbio Laboratory with the FDA for Direct Bilirubin Liquicolor And Total Bilirubin Liquicolor.
| Device ID | K050266 |
| 510k Number | K050266 |
| Device Name: | DIRECT BILIRUBIN LIQUICOLOR AND TOTAL BILIRUBIN LIQUICOLOR |
| Classification | Enzymatic Method, Bilirubin |
| 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 | JFM |
| CFR Regulation Number | 862.1110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-02-04 |
| Decision Date | 2005-06-30 |
| Summary: | summary |