QUANTA LITE PBC SCREEN IGG/IGA ELISA
FDA 510(k) clearance K061842 · decided 2006-10-18
Clearance details
- K-number
- K061842
- Device name
- QUANTA LITE PBC SCREEN IGG/IGA ELISA
- Applicant
- Inova Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-06-29
- Decision date
- 2006-10-18
- Days to decision
- 111 days
- Clearance type
- Traditional
- Product code
- NRI
- Device class
- 2
- Regulation number
- 866.5090
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- San Diego, CA, 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 |
|---|---|---|
| QUANTA LITE GP210 ELISA (K040885) | Inova Diagnostics, Inc. | 2004-06-25 |
Recalls involving this device
No recalls on record reference this clearance.