ARK LAMOTRIGINE ASSAY, CALIBRATOR & CONTROL
FDA 510(k) clearance K101305 · decided 2010-10-29
Clearance details
- K-number
- K101305
- Device name
- ARK LAMOTRIGINE ASSAY, CALIBRATOR & CONTROL
- Applicant
- Ark Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-05-10
- Decision date
- 2010-10-29
- Days to decision
- 172 days
- Clearance type
- Traditional
- Product code
- ORH
- Device class
- 2
- Regulation number
- 862.3350
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Sunnyvale, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Ark Diagnostics
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| QMS LAMOTRIGINE ASSAY (REAGENTS), CALIBRATORS & CONTROLS (K062966) | Seradyn, Inc. | 2007-01-12 |
Recalls involving this device
No recalls on record reference this clearance.