| Device Type ID | 2846 |
| Device Name | System, Delivery, Allergen And Vaccine |
| Review Panel | General Hospital |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) General Hospital Devices Branch (GHDB) |
| Submission Type | 510(k) |
| FDA Device Classification | Class Unclassified Medical Device |
| Product Code | LDH |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2846 |
| Device | System, Delivery, Allergen And Vaccine |
| Product Code | LDH |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
PROCARE INDUSTRIAL CO., LIMITED | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Material Integrity Problem | 1 |
Fracture | 1 |
| Total Device Problems | 2 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Allergy Laboratories, Inc. | II | Sep-12-2016 |
| 2 | Medscience Inc | II | May-31-2016 |