Device Type ID | 2924 |
Device Name | Albumin, Antigen, Antiserum, Control |
Regulation Description | Albumin 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) Exempt |
CFR Regulation Number | 866.5040 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | DCF |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 2924 |
Device | Albumin, Antigen, Antiserum, Control |
Product Code | DCF |
FDA Device Classification | Class 2 Medical Device |
Regulation Description | Albumin Immunological Test System. |
CFR Regulation Number | 866.5040 [🔎] |
Premarket Reviews | ||
---|---|---|
Manufacturer | Decision | |
BECKMAN COULTER IRELAND INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
THE BINDING SITE GROUP LTD | ||
SUBSTANTIALLY EQUIVALENT | 2 |
Device Problems | |
---|---|
Low Test Results | 2 |
Incorrect Or Inadequate Test Results | 2 |
Device Ingredient Or Reagent | 1 |
Non Reproducible Results | 1 |
Total Device Problems | 6 |
Recalls | |||
---|---|---|---|
Manufacturer | Recall Class | Date Posted | |
1 | Beckman Coulter Inc. | II | May-22-2017 |