RESOLVE HEMOGLOBIN KIT, JB-2 STAINING SYSTEM, MODELS FR-9120, FR-9400, FR-9360, FR-9367
FDA 510(k) clearance K050709 · decided 2006-03-08
Clearance details
- K-number
- K050709
- Device name
- RESOLVE HEMOGLOBIN KIT, JB-2 STAINING SYSTEM, MODELS FR-9120, FR-9400, FR-9360, FR-9367
- Applicant
- Wallac OY
- Decision
- Substantially Equivalent
- Date received
- 2005-03-18
- Decision date
- 2006-03-08
- Days to decision
- 355 days
- Clearance type
- Traditional
- Product code
- GKA
- Device class
- 2
- Regulation number
- 864.7415
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Turku, FI
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Multiphor II Electrophoresis System GE HealthCare Product Number: 18-1018-06 PerkinElmer P recall (Z-2685-2017) | Perkinelmer Life Sciences, Inc. | 2017-05-22 |