QMS LAMOTRIGINE ASSAY (REAGENTS), CALIBRATORS & CONTROLS
FDA 510(k) clearance K062966 · decided 2007-01-12
Clearance details
- K-number
- K062966
- Device name
- QMS LAMOTRIGINE ASSAY (REAGENTS), CALIBRATORS & CONTROLS
- Applicant
- Seradyn, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-09-29
- Decision date
- 2007-01-12
- Days to decision
- 105 days
- Clearance type
- Traditional
- Product code
- ORH
- Device class
- 2
- Regulation number
- 862.3350
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Indianapolis, IN, 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 |
|---|---|---|
| ARK LAMOTRIGINE ASSAY, CALIBRATOR & CONTROL (K101305) | Ark Diagnostics, Inc. | 2010-10-29 |
Recalls involving this device
No recalls on record reference this clearance.