QUANTA FLASH RO52, QUANTA FLASH RO52 CALIBRATORS, AND QUANTA FLASH RO52 CONTROLS
FDA 510(k) clearance K141655 · decided 2015-03-05
Clearance details
- K-number
- K141655
- Device name
- QUANTA FLASH RO52, QUANTA FLASH RO52 CALIBRATORS, AND QUANTA FLASH RO52 CONTROLS
- Applicant
- Inova Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2014-06-20
- Decision date
- 2015-03-05
- Days to decision
- 258 days
- Clearance type
- Traditional
- Product code
- OBE
- Device class
- 2
- Regulation number
- 866.5100
- 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 |
|---|---|---|
| Alegria Flash SSA-60; Alegria Flash SSA-52; Alegria FLash SSB (K250814) | Zeus Scientific | 2026-05-08 |
| QUANTA LITE SS-A 52 ELISA (K063565) | Inova Diagnostics, Inc. | 2007-04-04 |
Recalls involving this device
No recalls on record reference this clearance.