QUANTA Flash® LKM-1 Reagents, QUANTA Flash® LKM-1 Calibrators, QUANTA Flash® LKM-1 Controls
FDA 510(k) clearance K163538 · decided 2017-09-06
Clearance details
- K-number
- K163538
- Device name
- QUANTA Flash® LKM-1 Reagents, QUANTA Flash® LKM-1 Calibrators, QUANTA Flash® LKM-1 Controls
- Applicant
- Inova Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2016-12-16
- Decision date
- 2017-09-06
- Days to decision
- 264 days
- Clearance type
- Traditional
- Product code
- NBS
- Device class
- 2
- Regulation number
- 866.5660
- 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 |
|---|---|---|
| EUROIMMUN ANTI-LKM-1 ELISA(LGG) (K112223) | Euroimmun US | 2012-09-11 |
| QUANTA LITE LKM-1 ELISA (K000535) | Inova Diagnostics, Inc. | 2000-06-07 |
Recalls involving this device
No recalls on record reference this clearance.