The following data is part of a premarket notification filed by Wallac Oy with the FDA for Resolve Hemoglobin Kit, Jb-2 Staining System, Models Fr-9120, Fr-9400, Fr-9360, Fr-9367.
| Device ID | K050709 |
| 510k Number | K050709 |
| Device Name: | RESOLVE HEMOGLOBIN KIT, JB-2 STAINING SYSTEM, MODELS FR-9120, FR-9400, FR-9360, FR-9367 |
| Classification | Abnormal Hemoglobin Quantitation |
| Applicant | WALLAC OY MUSTIONKATU 6 Turku, FI 20750 |
| Contact | Raija Koskivaara |
| Correspondent | Raija Koskivaara WALLAC OY MUSTIONKATU 6 Turku, FI 20750 |
| Product Code | GKA |
| CFR Regulation Number | 864.7415 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-03-18 |
| Decision Date | 2006-03-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06438147246137 | K050709 | 000 |
| 06438147246120 | K050709 | 000 |
| 06438147000814 | K050709 | 000 |
| 06438147000807 | K050709 | 000 |
| 06438147000791 | K050709 | 000 |
| 06438147000784 | K050709 | 000 |