510(k) K081248
- Device
- QUANTA LITE OMP PLUS ELISA
- Applicant
- INOVA DIAGNOSTICS, INC.
- 510(k) number
- K081248
- Product code
- OKM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2008-10-27
- Date received
- 2008-05-02
- Regulation
- 866.5785
- Classification name
- Antibodies, Outer-membrane Proteins
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- ZAKERA SHUMS
- Address
- 9900 Old Grove Rd. San Diego CA US 92131 92131
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
Decision Summary