FDA Product Code
FDA Product Code NIG — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.6010
510(k) Clearances — 12 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K253528 | Atellica IM CA 19-9 II | Siemens Healthcare Diagnostics, Inc. | 2026-08-10 | Traditional | PDF ↗ |
| K231525 | VITROS Immunodiagnostic Products CA 19-9TM Reagent Pack | Ortho Clinical Diagnostics | 2023-08-09 | Traditional | PDF ↗ |
| K200997 | Lumipulse G CA19-9-N | Fujirebio Diagnostics,Inc. | 2020-05-14 | Special | PDF ↗ |
| K191973 | Lumpipulse G CA19-9-N | Fujirebio Dianostics, Inc. | 2019-10-22 | Traditional | PDF ↗ |
| K100375 | DIMENSION VISTA LOCI CA 19-9 FLEX REAGENT CARTRIDGE, AND DIMENSION LOCI7 CALIBRATOR WITH MODEL(S) K6457, AND KC604 | Siemens Healthcare Diagnostics, Inc. | 2011-04-06 | Traditional | PDF ↗ |
| K052889 | VITROS CA 19-9 | Fujirebio Diagnostics,Inc. | 2005-12-20 | Traditional | PDF ↗ |
| K052000 | ARCHITECT CA 19-9XR ASSAY | Fujirebio Diagnostics,Inc. | 2005-10-25 | Traditional | PDF ↗ |
| K033038 | GI MONITOR AND GI MONITOR CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 387687, 387688 | Beckman Coulter, Inc. | 2003-12-29 | Traditional | PDF ↗ |
| K031393 | BAYER ADVIA CENTAUR CA 19-9 ASSAY | Bayer Healthcare, LLC | 2003-06-24 | Traditional | PDF ↗ |
| K023240 | ST AIA-PACK CA 19-9 | Tosoh Corp. | 2002-12-23 | Traditional | PDF ↗ |
| K023239 | AIA-PACK CA 19-9 | Tosoh Corp. | 2002-12-23 | Traditional | PDF ↗ |
| K020566 | FUJIREBIO DIAGNOSTICS CA 19-9 RIA | Fujirebio Diagnostics,Inc. | 2002-05-09 | Traditional | PDF ↗ |
Product code NIG · Class II · Immunology. Data: openFDA.