ROCHE DIAGNOSTICS TINA-QUANT IGA GEN.2
FDA 510(k) clearance K040435 · decided 2004-03-10
Clearance details
- K-number
- K040435
- Device name
- ROCHE DIAGNOSTICS TINA-QUANT IGA GEN.2
- Applicant
- Roche Diagnostics Corp.
- Decision
- Substantially Equivalent
- Date received
- 2004-02-19
- Decision date
- 2004-03-10
- Days to decision
- 20 days
- Clearance type
- Special
- Product code
- CZP
- Device class
- 2
- Regulation number
- 866.5510
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Indianapolis, IN, US
- Third-party review
- No
- Expedited review
- No
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| N LATEX IGA (K952309) | Behring Diagnostics, Inc. | 1995-06-20 |
| IGA SUBCLASS RID KIT FOR DIAGNOSTIC USE (K931806) | The Binding Site, Ltd. | 1993-07-16 |
| IL TEST IMMUNOGLOBULIN A (K920014) | Instrumentation Laboratory CO | 1992-06-16 |
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
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