APOLIPOPROTEIN A1
FDA 510(k) clearance K983289 · decided 1999-01-29
Clearance details
- K-number
- K983289
- Device name
- APOLIPOPROTEIN A1
- Applicant
- Abbott Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1998-09-18
- Decision date
- 1999-01-29
- Days to decision
- 133 days
- Clearance type
- Traditional
- Product code
- DER
- Device class
- 2
- Regulation number
- 866.5580
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Irving, TX, US
- Third-party review
- No
- Expedited review
- No
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| Record | Firm | Date |
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| TINA-QUANT APOLIPOPROTEIN VER.2 (K013249) | Roche Diagnostics Corp. | 2001-11-16 |
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| K-ASSAY APO B (K993354) | Kamiya Biomedical Co. | 1999-10-28 |
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| INTEGRA REAGENT CASSETTE FOR APOLIPOPROTEIN A-1 (K990594) | Roche Diagnostics Corp. | 1999-04-14 |
| N-ASSAY TIA APO A1/B MULTI CALIBRATOR (K964294) | Crestat Diagnostics, Inc. | 1997-08-01 |
| N-ASSAY TIA APO B TEST KIT (K964296) | Crestat Diagnostics, Inc. | 1997-08-01 |
| N-ASSAY TIA APO A1 TEST KIT (K964292) | Crestat Diagnostics, Inc. | 1997-08-01 |
| ROCHE APOLIPOPROTEIN STANDARD (K910553) | Roche Diagnostic Systems, Inc. | 1991-05-08 |
| UC IMU A (K904125) | Eucardio Laboratory, Inc. | 1990-09-24 |
| QC3 WHOLE HUMAN SERUM, HDL-CHOLESTEROL CONTROL (K872078) | Solomon Park Research Laboratories | 1987-06-18 |
| APO-SCREEN CALIBRATOR & CONTROL SET FOR HDL APO A1 (K854875) | Photec Diagnostics, Inc. | 1986-01-24 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Clinical Chemistry Apolipoprotein A1, List Number 9D92-20 recall (Z-0383-06) | Abbott Laboratories Diagnostic Div | 2006-01-11 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| ARCHITECT CORE / Alinity i Anti-HBc (P080023/S046) | Abbott Laboratories | 2025-04-03 |
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| ARCHITECT Free PSA / Alinity i Free PSA (P980007/S055) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT HBsAg Qualitative/Qualitative Confirmatory / Alinity i HBsAg Qualitative II/Qualitative II Confirmatory (P110029/S052) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT HBsAg Next Qualitative / ARCHITECT HBsAg Next Confirmatory/ Alinity i HBsAg Next Qualitative/Alinity i HBsAg N (P210003/S013) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT HBsAg Next Qualitative/Next Confirmatory, Alinity i HBsAg Next Qualitative/Next Confirmatory (P210003/S012) | Abbott Laboratories | 2024-09-30 |