510(k) DEN120012
- Device
- CDC DENV-1-4 REAL TIME RT-PCT ASSAY
- Applicant
- Centers for Disease Control and Prevention
- 510(k) number
- DEN120012
- Product code
- OZB
- Decision
- Unknown (DENG)
- Decision date
- 2012-05-24
- Date received
- 2012-03-12
- Regulation
- 866.3946
- Classification name
- Dengue Nucleic Acid Amplification Assay (Naat)
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Post-NSE
- Third party reviewed
- N
Applicant Contact#
- Contact
- HYE-JOO KIM
- Address
- 1600 Clifton Rd., NE Atlanta GA US 30333 30333
FDA Registration Numbers#
- 3005360469
- 2032682
- 1050190
- 2243471
Source Documents#
510(k) summary PDF not indicated by FDA