| Device Type ID | 2996 |
| Device Name | System, Test, Radioallergosorbent (rast) Immunological |
| Regulation Description | Radioallergosorbent (RAST) Immunological Test System. |
| Regulation Medical Specialty | Immunology |
| Review Panel | Immunology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 866.5750 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | DHB |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 2996 |
| Device | System, Test, Radioallergosorbent (rast) Immunological |
| Product Code | DHB |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Radioallergosorbent (RAST) Immunological Test System. |
| CFR Regulation Number | 866.5750 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
HITACHI CHEMICAL DIAGNOSTICS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
HITACHI MEDICAL CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
HYCOR BIOMEDICAL | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PHADIA AB | ||
SUBSTANTIALLY EQUIVALENT | 5 | |
SIEMENS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SIEMENS HEALTHCARE DIAGNOSTICS INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 13 |
Shipping Damage Or Problem | 3 |
Device Handling Problem | 2 |
Manufacturing, Packaging Or Shipping Problem | 1 |
| Total Device Problems | 19 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Phadia Ab | II | Mar-30-2018 |
| 2 | Phadia US Inc | II | Apr-05-2018 |
| 3 | Phadia US Inc | II | Jan-18-2018 |
| 4 | Phadia US Inc | II | Jan-12-2015 |
| 5 | Siemens Healthcare Diagnostics, Inc. | II | May-04-2018 |
| 6 | Siemens Healthcare Diagnostics, Inc. | II | Jun-25-2015 |