The following data is part of a premarket notification filed by Hemocue, Inc. with the FDA for Hemocue B-hemoglobin System.
| Device ID | K961312 |
| 510k Number | K961312 |
| Device Name: | HEMOCUE B-HEMOGLOBIN SYSTEM |
| Classification | System, Hemoglobin, Automated |
| Applicant | HEMOCUE, INC. C/O ROBERT JOEL SLOMOF 9229 CRANFORD DRIVE Potomac, MD 20854 |
| Contact | Robert J Slomof |
| Correspondent | Robert J Slomof HEMOCUE, INC. C/O ROBERT JOEL SLOMOF 9229 CRANFORD DRIVE Potomac, MD 20854 |
| Product Code | GKR |
| CFR Regulation Number | 864.5620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-04 |
| Decision Date | 1996-09-24 |