510(k) K100287
- Device
- JBAIDS INFLUENZA A/H5 DETECTION KIT, MODEL JRPD-ASY-0136
- Applicant
- U.S. ARMY MEDICAL MATERIAL DEVELOPMENT COMMAND
- 510(k) number
- K100287
- Product code
- NXD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2010-07-06
- Date received
- 2010-01-29
- 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
- ROBERT E MILLER
- Address
- 1430 Veterans Dr. Fort Detrick MD US
FDA Registration Numbers#
- 3002777243
Source Documents#
Other 510(k) Records For Product Code NXD #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K080570 | CDC HUMAN INFLUENZA VIRUS REAL-TIME RT- PCR DETECTION AND CHARACTERIZATION PANEL | Centers for Disease Control and Prevention | 2008-09-30 |
| 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