FDA Product Code
FDA Product Code DER — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.5580
510(k) Clearances — 17 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K013249 | TINA-QUANT APOLIPOPROTEIN VER.2 | Roche Diagnostics Corp. | 2001-11-16 | Traditional | PDF ↗ |
| K000921 | BAYER ADVIA IMS SYSTEM; 200 + 3 | Bayer Corp. | 2000-05-18 | Traditional | PDF ↗ |
| K993354 | K-ASSAY APO B | Kamiya Biomedical Co. | 1999-10-28 | Traditional | PDF ↗ |
| K993345 | K-ASSAY APO AI | Kamiya Biomedical Co. | 1999-10-25 | Traditional | PDF ↗ |
| K990594 | INTEGRA REAGENT CASSETTE FOR APOLIPOPROTEIN A-1 | Roche Diagnostics Corp. | 1999-04-14 | Traditional | PDF ↗ |
| K983289 | APOLIPOPROTEIN A1 | Abbott Laboratories | 1999-01-29 | Traditional | PDF ↗ |
| K964292 | N-ASSAY TIA APO A1 TEST KIT | Crestat Diagnostics, Inc. | 1997-08-01 | Traditional | PDF ↗ |
| K964294 | N-ASSAY TIA APO A1/B MULTI CALIBRATOR | Crestat Diagnostics, Inc. | 1997-08-01 | Traditional | PDF ↗ |
| K964296 | N-ASSAY TIA APO B TEST KIT | Crestat Diagnostics, Inc. | 1997-08-01 | Traditional | PDF ↗ |
| K910553 | ROCHE APOLIPOPROTEIN STANDARD | Roche Diagnostic Systems, Inc. | 1991-05-08 | Traditional | PDF ↗ |
| K904125 | UC IMU A | Eucardio Laboratory, Inc. | 1990-09-24 | Traditional | PDF ↗ |
| K872078 | QC3 WHOLE HUMAN SERUM, HDL-CHOLESTEROL CONTROL | Solomon Park Research Laboratories | 1987-06-18 | Traditional | PDF ↗ |
| K854875 | APO-SCREEN CALIBRATOR & CONTROL SET FOR HDL APO A1 | Photec Diagnostics, Inc. | 1986-01-24 | Traditional | PDF ↗ |
| K853048 | APO-SCREEN TEST SET FOR HDL-APOLIPOPTEIN A-1 | Photec Diagnostics, Inc. | 1985-08-28 | Traditional | PDF ↗ |
| K851649 | APO A-I IMMUNOASSAY TEST SET FOR APOLIPOPROTEIN A1 | Photec Diagnostics, Inc. | 1985-06-05 | Traditional | PDF ↗ |
| K840830 | VENTRIA APO A-1 ALPHA-1 LIPOTROTEIN | Ventrex Laboratories, Inc. | 1984-05-21 | Traditional | PDF ↗ |
| K802610 | ALERT A,HDL-APOLIPOROTEIN A, TEST KIT | Hyland Therapeutic Div., Travenol Laboratories | 1981-01-05 | Traditional | PDF ↗ |
Product code DER · Class II · Immunology. Data: openFDA.