The following data is part of a premarket notification filed by Hemocue Ab with the FDA for Hemocue Hb 801 System.
| Device ID | K181751 |
| 510k Number | K181751 |
| Device Name: | HemoCue Hb 801 System |
| Classification | System, Hemoglobin, Automated |
| Applicant | HemoCue AB Kuvettgatan 1 Angelholm, SE 26271 |
| Contact | Maria Fagerberg |
| Correspondent | Maria Fagerberg HemoCue AB Kuvettgatan 1 Angelholm, SE 26271 |
| Product Code | GKR |
| CFR Regulation Number | 864.5620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-02 |
| Decision Date | 2019-02-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07311091219206 | K181751 | 000 |
| 17311091119022 | K181751 | 000 |