510(k) K091468
- Device
- IVD TECHNOLOGIES ACHRAB TEST KIT
- Applicant
- IVD TECHNOLOGIES
- 510(k) number
- K091468
- Product code
- NST
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2009-11-20
- Date received
- 2009-05-18
- 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
- Gary Lehnus
- Address
- 150 Cherry Ln. Rd. East Stroudsburg PA US 18301 18301
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 |
|---|---|---|---|
| K080523 | KRONUS BLOCKING ACETYLCHOLINE RECEPTOR AUTOANTIBODY (ACHRAB) RIA ASSAY KIT | Kronus Market Development Associates, Inc. | 2008-06-17 |
| 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