The following data is part of a premarket notification filed by Hemocue, Inc. with the FDA for Hemocue Hemoglobin 201 + System Article 121704.
| Device ID | K032203 |
| 510k Number | K032203 |
| Device Name: | HEMOCUE HEMOGLOBIN 201 + SYSTEM ARTICLE 121704 |
| 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 | 2003-07-18 |
| Decision Date | 2003-08-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07311091217219 | K032203 | 000 |
| 07311091217202 | K032203 | 000 |
| 07311091117328 | K032203 | 000 |
| 07311091117311 | K032203 | 000 |
| 07311091117168 | K032203 | 000 |
| 07311091117151 | K032203 | 000 |