Panels › Immunology › Product code NIG · Class 2
System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer
Regulation 866.6010
1510(k)s in 12 months (12 all time)
0recalls in 12 months (19 all time)
14recalls that name a 510(k)
Top companies in NIG
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 10, 2026 | K253528 | Atellica IM CA 19-9 II Siemens Healthcare Diagnostics, Inc. | NIG |
| Aug 9, 2023 | K231525 | VITROS Immunodiagnostic Products CA 19-9TM Reagent Pack Ortho Clinical Diagnostics, GB | NIG |
| May 14, 2020 | K200997 | Lumipulse G CA19-9-N Fujirebio Diagnostics,Inc. | NIG |
| Oct 22, 2019 | K191973 | Lumpipulse G CA19-9-N Fujirebio Dianostics, Inc. | NIG |
| Apr 6, 2011 | K100375 | DIMENSION VISTA LOCI CA 19-9 FLEX REAGENT CARTRIDGE, AND DIMENSION LOCI7 CALIBRATOR WITH MODEL(S) K6457, AND KC604 Siemens Healthcare Diagnostics, Inc. | NIG |
| Dec 20, 2005 | K052889 | VITROS CA 19-9 Fujirebio Diagnostics,Inc. | NIG |
| Oct 25, 2005 | K052000 | ARCHITECT CA 19-9XR ASSAY Fujirebio Diagnostics,Inc. | NIG |
| Dec 29, 2003 | K033038 | GI MONITOR AND GI MONITOR CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 387687, 387688 Beckman Coulter, Inc. | NIG |
| Jun 24, 2003 | K031393 | BAYER ADVIA CENTAUR CA 19-9 ASSAY Bayer Healthcare, LLC | NIG |
| Dec 23, 2002 | K023240 | ST AIA-PACK CA 19-9 Tosoh Corp. | NIG |
| Dec 23, 2002 | K023239 | AIA-PACK CA 19-9 Tosoh Corp. | NIG |
| May 9, 2002 | K020566 | FUJIREBIO DIAGNOSTICS CA 19-9 RIA Fujirebio Diagnostics,Inc. | NIG |
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