CERULOPLASMIN, MODEL 2055953
FDA 510(k) clearance K062114 · decided 2007-01-31
Clearance details
- K-number
- K062114
- Device name
- CERULOPLASMIN, MODEL 2055953
- Applicant
- Roche Diagnostics Corp.
- Decision
- Substantially Equivalent
- Date received
- 2006-07-24
- Decision date
- 2007-01-31
- Days to decision
- 191 days
- Clearance type
- Traditional
- Product code
- CHN
- Device class
- 2
- Regulation number
- 866.5210
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Indianapolis, IN, 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.
| Record | Firm | Date |
|---|---|---|
| TINA-QUANT CERULOPLASMIN (K091741) | Roche Diagnostics | 2010-03-18 |
| DIMENSION VISTA; CER FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, PROTEIN 1 CONTROL MEDIUM, PROTEIN 1 CONTROL HIGH (K063655) | Dade Behring, Inc. | 2007-02-15 |
Recalls involving this device
No recalls on record reference this clearance.
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