KRONUS GAD AUTOANTIBODY ELISA ASSAY KIT
FDA 510(k) clearance K072135 · decided 2007-11-07
Clearance details
- K-number
- K072135
- Device name
- KRONUS GAD AUTOANTIBODY ELISA ASSAY KIT
- Applicant
- Kronus Market Development Associates, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-08-02
- Decision date
- 2007-11-07
- Days to decision
- 97 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
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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 |
|---|---|---|
| KRONUS GLUTAMIC ACID DECARBOXYLASE ANTIBODY KIT (K051061) | Kronus Market Development Associates, Inc. | 2005-11-04 |
Recalls involving this device
No recalls on record reference this clearance.