510(k) K051061
- Device
- KRONUS GLUTAMIC ACID DECARBOXYLASE ANTIBODY KIT
- Applicant
- KRONUS MARKET DEVELOPMENT ASSOCIATES, INC.
- 510(k) number
- K051061
- Product code
- NWG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2005-11-04
- Date received
- 2005-04-26
- Regulation
- 866.5660
- Classification name
- Autoantibodies, Glutamic Acid Decarboxylase (gad)
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- MEATHER VIELE
- Address
- 12554 W. Bridger St. Suite 108 Boise ID US 83713 83713
FDA Registration Numbers#
- 3003834021
- 2025560
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code NWG #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K072135 | KRONUS GAD AUTOANTIBODY ELISA ASSAY KIT | Kronus Market Development Associates, Inc. | 2007-11-07 |
Legacy Summary#
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FDA Review#
Decision Summary