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 & B Detection Kit.
| Device ID | K152523 |
| 510k Number | K152523 |
| Device Name: | JBAIDS Influenza A & B Detection Kit |
| Classification | Respiratory Virus Panel Nucleic Acid Assay System |
| Applicant | U.S. ARMY MEDICAL MATERIEL DEVELOPMENT ACTIVITY 1430 VETERANS DRIVE Fort Detrick, MD 21702 -9232 |
| Contact | Robert E Miller |
| Correspondent | Robert E Miller U.S. ARMY MEDICAL MATERIEL DEVELOPMENT ACTIVITY 1430 VETERANS DRIVE Fort Detrick, MD 21702 -9232 |
| Product Code | OCC |
| CFR Regulation Number | 866.3980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-03 |
| Decision Date | 2015-10-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851458005068 | K152523 | 000 |