The following data is part of a premarket notification filed by Stanbio Laboratory with the FDA for Stanbio Laboratory Hemopoint H2 Hemoglobin Measurement System.
| Device ID | K081719 |
| 510k Number | K081719 |
| Device Name: | STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM |
| Classification | System, Hemoglobin, Automated |
| 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 | GKR |
| CFR Regulation Number | 864.5620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-06-18 |
| Decision Date | 2008-07-18 |
| Summary: | summary |