Product code DER
- Device name
- Alpha-1-Lipoprotein, Antigen, Antiserum, Control
- Medical specialty
- Immunology
- Device class
- 2
- Regulation number
- 866.5580
- Review panel
- IM
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K013249 | TINA-QUANT APOLIPOPROTEIN VER.2 | Roche Diagnostics Corp. | 2001-11-16 |
| K000921 | BAYER ADVIA IMS SYSTEM; 200 + 3 | Bayer Corp. | 2000-05-18 |
| K993354 | K-ASSAY APO B | Kamiya Biomedical Co. | 1999-10-28 |
| K993345 | K-ASSAY APO AI | Kamiya Biomedical Co. | 1999-10-25 |
| K990594 | INTEGRA REAGENT CASSETTE FOR APOLIPOPROTEIN A-1 | Roche Diagnostics Corp. | 1999-04-14 |
| K983289 | APOLIPOPROTEIN A1 | Abbott Laboratories | 1999-01-29 |
| K964292 | N-ASSAY TIA APO A1 TEST KIT | Crestat Diagnostics, Inc. | 1997-08-01 |
| K964294 | N-ASSAY TIA APO A1/B MULTI CALIBRATOR | Crestat Diagnostics, Inc. | 1997-08-01 |
| K964296 | N-ASSAY TIA APO B TEST KIT | Crestat Diagnostics, Inc. | 1997-08-01 |
| K910553 | ROCHE APOLIPOPROTEIN STANDARD | Roche Diagnostic Systems, Inc. | 1991-05-08 |
| K904125 | UC IMU A | Eucardio Laboratory, Inc. | 1990-09-24 |
| K872078 | QC3 WHOLE HUMAN SERUM, HDL-CHOLESTEROL CONTROL | Solomon Park Research Laboratories | 1987-06-18 |
| K854875 | APO-SCREEN CALIBRATOR & CONTROL SET FOR HDL APO A1 | Photec Diagnostics, Inc. | 1986-01-24 |
| K853048 | APO-SCREEN TEST SET FOR HDL-APOLIPOPTEIN A-1 | Photec Diagnostics, Inc. | 1985-08-28 |
| K851649 | APO A-I IMMUNOASSAY TEST SET FOR APOLIPOPROTEIN A1 | Photec Diagnostics, Inc. | 1985-06-05 |
| K840830 | VENTRIA APO A-1 ALPHA-1 LIPOTROTEIN | Ventrex Laboratories, Inc. | 1984-05-21 |
| K802610 | ALERT A,HDL-APOLIPOROTEIN A, TEST KIT | Hyland Therapeutic Div., Travenol Laboratories | 1981-01-05 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00380740170141 | ARCHITECT | ABBOTT IRELAND | 2023-08-10 |
| 00380740170134 | Alinity | ABBOTT IRELAND | 2021-05-19 |
| 00380740175139 | ARCHITECT | Abbott GmbH | 2021-02-18 |
| 07613336133521 | Tina-quant Apolipoprotein A-1 ver.2 | Roche Diagnostics GmbH | 2020-03-16 |
| 00380740153908 | Alinity | Abbott GmbH | 2019-07-03 |
| 04015630917747 | AI ver2 Tinaquant Apolipoprotein AI ver2 | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630928651 | Tinaquant Apolipoprotein A1 ver2 | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630930227 | Tinaquant Apolipoprotein AI ver2 | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630917723 | Tinaquant Apolipoprotein A1 ver2 | Roche Diagnostics GmbH | 2016-09-20 |
| 00816426020016 | K-ASSAY® Apo AI Reagent | KAMIYA BIOMEDICAL COMPANY, LLC | 2016-09-16 |
| 00816426020177 | K-ASSAY® Apo B Reagent (L) | KAMIYA BIOMEDICAL COMPANY, LLC | 2016-09-16 |
| 00816426020030 | K-ASSAY® Apo B Reagent | KAMIYA BIOMEDICAL COMPANY, LLC | 2016-09-16 |
| 00817302020878 | CAROLINA LIQUID CHEMISTRIES CORP.® APOA RGT. KIT BL-632 | CAROLINA LIQUID CHEMISTRIES CORPORATION | 2016-09-01 |
| 00817302020885 | CAROLINA LIQUID CHEMISTRIES CORP.® APOA RGT. KIT AU-632 | CAROLINA LIQUID CHEMISTRIES CORPORATION | 2016-09-01 |
| 00817302020892 | CAROLINA LIQUID CHEMISTRIES CORP.® APOB RGT. KIT BL-633 | CAROLINA LIQUID CHEMISTRIES CORPORATION | 2016-09-01 |
| 00817302020908 | CAROLINA LIQUID CHEMISTRIES CORP.® APOB RGT. KIT AU-633 | CAROLINA LIQUID CHEMISTRIES CORPORATION | 2016-09-01 |
| 00817302020915 | CAROLINA LIQUID CHEMISTRIES CORP.® APO B REAGENT CC633 | CAROLINA LIQUID CHEMISTRIES CORPORATION | 2016-09-01 |
| 00380740019716 | ARCHITECT | ABBOTT LABORATORIES | 2016-06-06 |