510(k) K080570
- Device
- CDC HUMAN INFLUENZA VIRUS REAL-TIME RT- PCR DETECTION AND CHARACTERIZATION PANEL
- Applicant
- CENTERS FOR DISEASE CONTROL AND PREVENTION
- 510(k) number
- K080570
- Product code
- NXD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2008-09-30
- Date received
- 2008-02-29
- 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
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- STEPHEN LINDSTROM
- Address
- 1600 Clifton Rd. Ms-C12 Atlanta GA US 30333 30333
FDA Registration Numbers#
- 3002777243
Source Documents#
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 |
| DEN060008 | INFLUENZA A/H5 (ASIAN LINEAGE) VIRUS REAL-TIME RT-PCR PRIMER AND PROBE SET | Centers for Disease Control and Prevention | 2006-02-03 |
Legacy Summary#
summary
FDA Review#
Decision Summary