KRONUS GLUTAMIC ACID DECARBOXYLASE ANTIBODY KIT
FDA 510(k) clearance K051061 · decided 2005-11-04
Clearance details
- K-number
- K051061
- Device name
- KRONUS GLUTAMIC ACID DECARBOXYLASE ANTIBODY KIT
- Applicant
- Kronus Market Development Associates, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-04-26
- Decision date
- 2005-11-04
- Days to decision
- 192 days
- Clearance type
- Traditional
- Product code
- NWG
- Device class
- 2
- Regulation number
- 866.5660
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Boise, ID, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Kronus Market Development Associates
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 |
|---|---|---|
| KRONUS GAD AUTOANTIBODY ELISA ASSAY KIT (K072135) | Kronus Market Development Associates, Inc. | 2007-11-07 |
Recalls involving this device
No recalls on record reference this clearance.