CDC HUMAN INFLUENZA VIRUS REAL-TIME RT- PCR DETECTION AND CHARACTERIZATION PANEL
FDA 510(k) clearance K080570 · decided 2008-09-30
Clearance details
- K-number
- K080570
- Device name
- CDC HUMAN INFLUENZA VIRUS REAL-TIME RT- PCR DETECTION AND CHARACTERIZATION PANEL
- Applicant
- Centers for Disease Control and Prevention
- Decision
- Substantially Equivalent
- Date received
- 2008-02-29
- Decision date
- 2008-09-30
- Days to decision
- 214 days
- Clearance type
- Traditional
- Product code
- NXD
- Device class
- 2
- Regulation number
- 866.3332
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Atlanta, GA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| JBAIDS INFLUENZA A/H5 DETECTION KIT, MODEL JRPD-ASY-0136 (K100287) | U.S. Army Medical Material Development Command | 2010-07-06 |
| INFLUENZA A/H5 (ASIAN LINEAGE) VIRUS REAL-TIME RT-PCR PRIMER AND PROBE SET (DEN060008) | Centers for Disease Control and Prevention | 2006-02-03 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| AFP MID-PREGNANCY REFERENCE PREPARATION (P820077) | Centers for Disease Control and Prevention | 1984-11-30 |