The following data is part of a premarket notification filed by U.s. Army Medical Materiel Development Activity with the FDA for Jbaids Influenza A Subtyping Kit.
| Device ID | K111778 |
| 510k Number | K111778 |
| Device Name: | JBAIDS INFLUENZA A SUBTYPING KIT |
| Classification | 2009 H1n1 Influenza Virus (swine Origin), Nucleic Acid Or Antigen, Detection And Identification |
| Applicant | U.S. ARMY MEDICAL MATERIEL DEVELOPMENT ACTIVITY 1430 VETERANS DRIVE Fort Detrick, MD 21702 |
| Contact | Patricia M Beverly |
| Correspondent | Patricia M Beverly U.S. ARMY MEDICAL MATERIEL DEVELOPMENT ACTIVITY 1430 VETERANS DRIVE Fort Detrick, MD 21702 |
| Product Code | OQW |
| Subsequent Product Code | OEP |
| Subsequent Product Code | OOI |
| CFR Regulation Number | 866.3332 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-06-23 |
| Decision Date | 2011-09-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851458005075 | K111778 | 000 |