510(k) DEN060008
- Device
- INFLUENZA A/H5 (ASIAN LINEAGE) VIRUS REAL-TIME RT-PCR PRIMER AND PROBE SET
- Applicant
- Centers for Disease Control and Prevention
- 510(k) number
- DEN060008
- Product code
- NXD
- Decision
- Unknown (DENG)
- Decision date
- 2006-02-03
- Date received
- 2006-01-27
- Regulation
- 866.3332
- Classification name
- Nucleic Acid Amplification, Novel Influenza A Virus, A/H5 (Asian Lineage) Rna
- 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 (Ms C-12) Atlanta GA US 30333 30333
FDA Registration Numbers#
- 3002777243
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code NXD#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K100287 | JBAIDS INFLUENZA A/H5 DETECTION KIT, MODEL JRPD-ASY-0136 | U.S. Army Medical Material Development Command | 2010-07-06 |
| K080570 | CDC HUMAN INFLUENZA VIRUS REAL-TIME RT- PCR DETECTION AND CHARACTERIZATION PANEL | Centers for Disease Control and Prevention | 2008-09-30 |