510(k) K063261
- Device
- NUCLISENS EASYQ ENTEROVIRUS SYSTEM
- Applicant
- BIOMERIEUX, INC.
- 510(k) number
- K063261
- Product code
- OAI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2008-06-23
- Date received
- 2006-10-30
- Regulation
- 866.3225
- Classification name
- Assay, Enterovirus Nucleic Acid
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- SANDRA PERREAND
- Address
- 100 Rodolphe St. Durham NC US 27712 27712
FDA Registration Numbers#
- 3004530258
Source Documents#
Other 510(k) Records For Product Code OAI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| DEN070004 | XPERT EV, MODEL GXEV-100N-10; GENEXPERT DX SYSTEM, MODELS P/N 900-0144, 900-0145, 900-0146, 900-0065 | Cepheid | 2007-03-16 |
Legacy Summary#
summary
FDA Review#
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