DEL — Lipoprotein X, Antigen, Antiserum, Control Class I
FDA Device Classification
Classification Details
- Product Code
- DEL
- Device Class
- Class I
- Regulation Number
- 866.5590
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Immunology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K013278 | roche diagnostics | TINA-QUANT APOLIPOPROTEIN A-1 VER.2 | November 15, 2001 |
| K901675 | sigma chemical | APOLIPOPROTEIN A-I (APO A-I) | April 26, 1990 |
| K900124 | sigma chemical | APOLIPOPROTEIN B (APO B) | March 2, 1990 |
| K895160 | medical marketing consultants | ORTHO *APO A-1 ELISA TEST SYSTEM | October 6, 1989 |
| K893885 | catachem | BACTON TM, BASIC TM, APO A-I REAGENT | June 21, 1989 |