The following data is part of a premarket notification filed by Hemocue Ab with the FDA for Hemocue Wbc System.
| Device ID | K071652 |
| 510k Number | K071652 |
| Device Name: | HEMOCUE WBC SYSTEM |
| Classification | Counter, Cell, Automated (particle Counter) |
| 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 | GKL |
| CFR Regulation Number | 864.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-06-18 |
| Decision Date | 2007-10-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07311091230010 | K071652 | 000 |
| 07311091130037 | K071652 | 000 |