The following data is part of a premarket notification filed by Hemocue, Inc. with the FDA for Hemocue Hemoglobin 201dm Analyzing System.
| Device ID | K041234 |
| 510k Number | K041234 |
| Device Name: | HEMOCUE HEMOGLOBIN 201DM ANALYZING SYSTEM |
| Classification | System, Hemoglobin, Automated |
| Applicant | HEMOCUE, INC. 9229 CRANFORD DR. Potomac, MD 20854 |
| Contact | R.j. Slomoff |
| Correspondent | R.j. Slomoff HEMOCUE, INC. 9229 CRANFORD DR. Potomac, MD 20854 |
| Product Code | GKR |
| CFR Regulation Number | 864.5620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-05-10 |
| Decision Date | 2004-06-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07311091211460 | K041234 | 000 |
| 07311091211354 | K041234 | 000 |