The following data is part of a premarket notification filed by Hemocue Ab with the FDA for Hemocue Albumin 201 Analyzing System.
| Device ID | K053253 |
| 510k Number | K053253 |
| Device Name: | HEMOCUE ALBUMIN 201 ANALYZING SYSTEM |
| Classification | Automated Urinalysis System |
| Applicant | HEMOCUE AB 40 EMPIRE DRIVE Lake Forest, CA 92630 |
| Contact | Allan White |
| Correspondent | Allan White HEMOCUE AB 40 EMPIRE DRIVE Lake Forest, CA 92630 |
| Product Code | KQO |
| CFR Regulation Number | 862.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-11-21 |
| Decision Date | 2006-02-17 |
| Summary: | summary |