DER — Alpha-1-Lipoprotein, Antigen, Antiserum, Control Class II
FDA product code DER covers "Alpha-1-Lipoprotein, Antigen, Antiserum, Control", a Class II medical device regulated under 21 CFR 866.5580. Submissions are reviewed by the Immunology panel. At least 17 recent 510(k) clearances have been granted under this product code.
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 |