Igm (Mu Chain Specific), Antigen, Antiserum, Control
FDA product code DAO · Class II (moderate risk) · 21 CFR 866.5550 · Immunology
8510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K040431 | Roche Diagnostics Tina-Quant Igm GEN.2DAO · Special | Roche Diagnostics Corp. | 03/10/2004SE |
| K982639 | Spife Urine IfeDAO · Traditional | Helena Laboratories | 11/04/1998SE |
| K955908 | Boehringer Mannheim Igm AssayDAO · Traditional | Boehringer Mannheim Corp. | 02/09/1996SE |
| K850586 | SPQ Test System for Immunoglobulin MDAO · Traditional | Applications Lab | 03/14/1985SE |
| K841992 | Modification to Acs Coronary GuidingDAO · Traditional | Advanced Cardiovascular Systems, Inc. | 06/11/1984SE |
| K812487 | Immunogl. Frct. of Rabbit Antiser.-IgmDAO · Traditional | Dako Corp. | 09/23/1981SE |
| K800450 | Gemeni Igm AssayDAO · Traditional | Electro-Nucleonics Laboratories, Inc. | 04/24/1980SE |
| K790705 | Antiserum to Human IgmDAO · Traditional | Kent Laboratories, Inc. | 04/12/1979SESP |