510(k) K080523
- Device
- KRONUS BLOCKING ACETYLCHOLINE RECEPTOR AUTOANTIBODY (ACHRAB) RIA ASSAY KIT
- Applicant
- KRONUS MARKET DEVELOPMENT ASSOCIATES, INC.
- 510(k) number
- K080523
- Product code
- NST
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2008-06-17
- Date received
- 2008-02-26
- Regulation
- 866.5660
- Classification name
- Autoantibodies, Acetylcholine Receptor, Acetylcholine Blocking And Non-blocking
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- HEATHER VIELE
- Address
- 12554 W. Bridger St. Suite 108 Boise ID US 83713 83713
FDA Registration Numbers#
- 3003834021
- 3003559191
- 9710337
- 2025560
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code NST #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K091468 | IVD TECHNOLOGIES ACHRAB TEST KIT | Ivd Technologies | 2009-11-20 |
| K051144 | ACETYLCHOLINE RECEPTOR AB (ARAB)RRA | Ibl-Hamburg GmbH | 2005-11-18 |
| K042248 | KRONUS, INC.'S ACETYLCHOLINE RECEPTOR ANTIBODY (ACHRAB) ASSAY KIT | Kronus Market Development Associates, Inc. | 2004-12-17 |
Legacy Summary#
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FDA Review#
Decision Summary