510(k) K092399
- Device
- ANTI-MUTATED CITRULLINATED VIMENTIN EIA
- Applicant
- ORGENTEC DIAGNOSTIKA GMBH
- 510(k) number
- K092399
- Product code
- OQZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2010-07-01
- Date received
- 2009-08-06
- Regulation
- 866.5775
- Classification name
- Anti-mutated Citrullinated Vimentin Igg
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Gary Lehnus
- Address
- 150 Cherry Ln. Rd. East Stroudsburg PA US 18301 18301
FDA Registration Numbers#
- 3003232042
Source Documents#
Legacy Summary#
summary
FDA Review#
Decision Summary