TINA-QUANT CRP (LATEX) HS TEST SYSTEM (C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE)
FDA 510(k) clearance K042485 · decided 2004-10-29
Clearance details
- K-number
- K042485
- Device name
- TINA-QUANT CRP (LATEX) HS TEST SYSTEM (C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE)
- Applicant
- Roche Diagnostics Corp.
- Decision
- Substantially Equivalent
- Date received
- 2004-09-13
- Decision date
- 2004-10-29
- Days to decision
- 46 days
- Clearance type
- Traditional
- Product code
- NQD
- Device class
- 2
- Regulation number
- 866.5270
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Indianapolis, IN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Tina-Quant (Latex) HS Test System (C-Reactive Protein (Latex) High Sensitive) The Tina-Qua recall (Z-1092-2017) | Roche Diagnostics Operations, Inc. | 2017-01-24 |
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