BAYER ADVIA CENTAUR CA 19-9 ASSAY
FDA 510(k) clearance K031393 · decided 2003-06-24
Clearance details
- K-number
- K031393
- Device name
- BAYER ADVIA CENTAUR CA 19-9 ASSAY
- Applicant
- Bayer Healthcare, LLC
- Decision
- Substantially Equivalent
- Date received
- 2003-05-02
- Decision date
- 2003-06-24
- Days to decision
- 53 days
- Clearance type
- Traditional
- Product code
- NIG
- Device class
- 2
- Regulation number
- 866.6010
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Tarrytown, NY, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Bayer Healthcare
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| VITROS Immunodiagnostic Products CA 19-9TM Reagent Pack (K231525) | Ortho Clinical Diagnostics | 2023-08-09 |
| Lumipulse G CA19-9-N (K200997) | Fujirebio Diagnostics,Inc. | 2020-05-14 |
| Lumpipulse G CA19-9-N (K191973) | Fujirebio Dianostics, Inc. | 2019-10-22 |
| DIMENSION VISTA LOCI CA 19-9 FLEX REAGENT CARTRIDGE, AND DIMENSION LOCI7 CALIBRATOR WITH MODEL(S) K6457, AND KC604 (K100375) | Siemens Healthcare Diagnostics, Inc. | 2011-04-06 |
| VITROS CA 19-9 (K052889) | Fujirebio Diagnostics,Inc. | 2005-12-20 |
| ARCHITECT CA 19-9XR ASSAY (K052000) | Fujirebio Diagnostics,Inc. | 2005-10-25 |
| GI MONITOR AND GI MONITOR CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 387687, 387688 (K033038) | Beckman Coulter, Inc. | 2003-12-29 |
| AIA-PACK CA 19-9 (K023239) | Tosoh Corp. | 2002-12-23 |
| ST AIA-PACK CA 19-9 (K023240) | Tosoh Corp. | 2002-12-23 |
| FUJIREBIO DIAGNOSTICS CA 19-9 RIA (K020566) | Fujirebio Diagnostics,Inc. | 2002-05-09 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Atellica IM CA 19-9 (50 Test)-In vitro diagnostic use in the quantitative measurement of t recall (Z-3100-2024) | Siemens Healthcare Diagnostics, Inc. | 2024-09-11 |
| Atellica IM CA 19-9 (250 Test)- In vitro diagnostic use in the quantitative measurement of recall (Z-3101-2024) | Siemens Healthcare Diagnostics, Inc. | 2024-09-11 |
| Atellica IM CA 19-9 (250 Test - REF)-In vitro diagnostic use in the quantitative measureme recall (Z-3102-2024) | Siemens Healthcare Diagnostics, Inc. | 2024-09-11 |
| ADVIA Centaur CA 19-9 (50 Test)-In vitro diagnostic use in the quantitative measurement of recall (Z-3103-2024) | Siemens Healthcare Diagnostics, Inc. | 2024-09-11 |
| ADVIA Centaur CA 19-9 (250 Test)-In vitro diagnostic use in the quantitative measurement o recall (Z-3104-2024) | Siemens Healthcare Diagnostics, Inc. | 2024-09-11 |
| Siemens Healthcare ADVIA Centaur CA 19-9 250 Test 10491244 50 Test 10491379 Intended Use T recall (Z-0508-2013) | Siemens Healthcare Diagnostics, Inc | 2012-12-11 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| ADVIA CENTAUR HAV IGM READY PACK REAGENTS, ADVIA CENTAUR HAV IGM QUALITY CONTROL MATERIALS (P040018) | Bayer Healthcare, LLC | 2004-12-22 |
| CIBA CORNING ACS PSA IMMUNOASSAY (P920030/S002) | Bayer Healthcare, LLC | 1998-12-08 |
| CIBA CORNING ACS PSA IMMUNOASSAY (P920030) | Bayer Healthcare, LLC | 1998-12-08 |
| CIBA CORNING ACS PSA IMMUNOASSAY (P920030/S001) | Bayer Healthcare, LLC | 1995-12-13 |