The following data is part of a premarket notification filed by Hemocue Ab with the FDA for Automated Hemoglobin System.
| Device ID | BK060048 |
| 510k Number | BK060048 |
| Device Name: | Automated Hemoglobin System |
| Classification | System, Hemoglobin, Automated |
| Applicant | HemoCue AB kuvettgatan 1 Angelholm, SE-262 71, SW |
| Product Code | GKR |
| CFR Regulation Number | 864.5620 [🔎] |
| Decision | Substantially Equivalent (SE) |
| Type | 510(k) Traditio |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-09 |
| Decision Date | 2006-10-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07311091118073 | BK060048 | 0 |
| 07311091118011 | BK060048 | 0 |
| 27311091118121 | BK060048 | 0 |
| 27311091118077 | BK060048 | 0 |
| 07311091118097 | BK060048 | 000 |