K-ASSAY (R) FERRITIN REAGENT, K-ASSAY (R) FERRITIN CALIBRATOR
FDA 510(k) clearance K121232 · decided 2012-05-24
Clearance details
- K-number
- K121232
- Device name
- K-ASSAY (R) FERRITIN REAGENT, K-ASSAY (R) FERRITIN CALIBRATOR
- Applicant
- Kamiya Biomedical Company
- Decision
- Substantially Equivalent
- Date received
- 2012-04-24
- Decision date
- 2012-05-24
- Days to decision
- 30 days
- Clearance type
- Traditional
- Product code
- DBF
- Device class
- 2
- Regulation number
- 866.5340
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Tukwila, WA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.