The following data is part of a premarket notification filed by Hemocue Ab with the FDA for Hemocue Hb 301 Analyzer, Model 121804 And Microcuvettes, Model 111801.
| Device ID | K061047 |
| 510k Number | K061047 |
| Device Name: | HEMOCUE HB 301 ANALYZER, MODEL 121804 AND MICROCUVETTES, MODEL 111801 |
| Classification | System, Hemoglobin, Automated |
| 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 | GKR |
| CFR Regulation Number | 864.5620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-04-14 |
| Decision Date | 2006-06-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 17311091218046 | K061047 | 000 |