DER — Alpha-1-Lipoprotein, Antigen, Antiserum, Control Class II
FDA Device Classification
Classification Details
- Product Code
- DER
- Device Class
- Class II
- Regulation Number
- 866.5580
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Immunology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K013249 | roche diagnostics | TINA-QUANT APOLIPOPROTEIN VER.2 | November 16, 2001 |
| K000921 | bayer | BAYER ADVIA IMS SYSTEM; 200 + 3 | May 18, 2000 |
| K993354 | kamiya biomedical | K-ASSAY APO B | October 28, 1999 |
| K993345 | kamiya biomedical | K-ASSAY APO AI | October 25, 1999 |
| K990594 | roche diagnostics | INTEGRA REAGENT CASSETTE FOR APOLIPOPROTEIN A-1 | April 14, 1999 |
| K983289 | abbott laboratories | APOLIPOPROTEIN A1 | January 29, 1999 |
| K964292 | crestat diagnostics | N-ASSAY TIA APO A1 TEST KIT | August 1, 1997 |
| K964296 | crestat diagnostics | N-ASSAY TIA APO B TEST KIT | August 1, 1997 |
| K964294 | crestat diagnostics | N-ASSAY TIA APO A1/B MULTI CALIBRATOR | August 1, 1997 |
| K910553 | roche diagnostic systems | ROCHE APOLIPOPROTEIN STANDARD | May 8, 1991 |
| K904125 | eucardio laboratory | UC IMU A | September 24, 1990 |
| K872078 | solomon park research laboratories | QC3 WHOLE HUMAN SERUM, HDL-CHOLESTEROL CONTROL | June 18, 1987 |
| K854875 | photec diagnostics | APO-SCREEN CALIBRATOR & CONTROL SET FOR HDL APO A1 | January 24, 1986 |
| K853048 | photec diagnostics | APO-SCREEN TEST SET FOR HDL-APOLIPOPTEIN A-1 | August 28, 1985 |
| K851649 | photec diagnostics | APO A-I IMMUNOASSAY TEST SET FOR APOLIPOPROTEIN A1 | June 5, 1985 |
| K840830 | ventrex laboratories | VENTRIA APO A-1 ALPHA-1 LIPOTROTEIN | May 21, 1984 |
| K802610 | hyland therapeutic div., travenol laboratories | ALERT A,HDL-APOLIPOROTEIN A, TEST KIT | January 5, 1981 |