ARK Lacosamide Assay
FDA 510(k) clearance K201089 · decided 2021-08-05
Clearance details
- K-number
- K201089
- Device name
- ARK Lacosamide Assay
- Applicant
- Ark Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2020-04-23
- Decision date
- 2021-08-05
- Days to decision
- 469 days
- Clearance type
- Traditional
- Product code
- NWM
- Device class
- 2
- Regulation number
- 862.3350
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Fremont, 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 |
|---|---|---|
| ARK ZONISAMIDE ASSAY, ARK ZONISAMIDE CALIBRATOR, AND ARK ZONISAMIDE CONTRO, MODELS 5022-0001-00, 5022-0002-00, 5022-0003 (K091884) | Ark Diagnostics, Inc. | 2009-12-09 |
| TOPIRAMATE ASSAY, ARK TOPIRAMATE CALIBRATOR AND ARK TOPIRAMATE CONTROL, MODELS 5015-0001-000, 5015-0002-00, 5015-0003-00 (K083799) | Ark Diagnostics, Inc. | 2009-04-16 |
| SERADYN QMS TOPIRAMATE (K070645) | Seradyn, Inc. | 2007-05-17 |
| QMS ZONISAMIDE REAGENTS, CALIBRATORS AND CONTROLS (K051211) | Seradyn, Inc. | 2005-11-18 |
Recalls involving this device
No recalls on record reference this clearance.