The following data is part of a premarket notification filed by Hemocue, Incorporated with the FDA for Automated Hemoglobin System.
| Device ID | BK000043 |
| 510k Number | BK000043 |
| Device Name: | Automated Hemoglobin System |
| Classification | System, Hemoglobin, Automated |
| Applicant | HemoCue, Incorporated 9229 Cranford Drive Potomac, MD 20854 US |
| 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 | 2000-11-13 |
| Decision Date | 2001-04-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07311091203144 | BK000043 | 0 |
| 07311091103024 | BK000043 | 0 |