510(k) K200997
- Device
- Lumipulse G CA19-9-N
- Applicant
- Fujirebio Diagnostics, Inc.
- 510(k) number
- K200997
- Product code
- NIG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2020-05-14
- Date received
- 2020-04-16
- Regulation
- 866.6010
- Classification name
- System, Test, Carbohydrate Antigen (ca19-9), For Monitoring And Management Of Pancreatic Cancer
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Kristin Maddaloni
- Address
- 201 Great Valley Pkwy. Malvern PA US 19355 19355
FDA Registration Numbers#
- 2517506
- 2432235
- 3007111389
- 3005333358
- 3000308930
- 3002809144
- 3002642396
- 9610126
- 8020888
- 3005360469
- 8031673
- 3012963943
- 2032839
- 2020726
- 2250051
- 2122870
- 3005529799
- 9612316
- 2521625
- 1219913
- 1319681
Source Documents#
Other 510(k) Records For Product Code NIG #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K231525 | VITROS Immunodiagnostic Products CA 19-9TM Reagent Pack | Ortho Clinical Diagnostics | 2023-08-09 |
| K191973 | Lumpipulse G CA19-9-N | Fujirebio Dianostics, Inc. | 2019-10-22 |
| 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 |
| K052889 | VITROS CA 19-9 | Fujirebio Diagnostics,Inc. | 2005-12-20 |
| K052000 | ARCHITECT CA 19-9XR ASSAY | Fujirebio Diagnostics,Inc. | 2005-10-25 |
| K033038 | GI MONITOR AND GI MONITOR CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 387687, 387688 | Beckman Coulter, Inc. | 2003-12-29 |
| K031393 | BAYER ADVIA CENTAUR CA 19-9 ASSAY | Bayer Healthcare, LLC | 2003-06-24 |
| K023239 | AIA-PACK CA 19-9 | Tosoh Corp. | 2002-12-23 |
| K023240 | ST AIA-PACK CA 19-9 | Tosoh Corp. | 2002-12-23 |
| K020566 | FUJIREBIO DIAGNOSTICS CA 19-9 RIA | Fujirebio Diagnostics,Inc. | 2002-05-09 |
Legacy Summary#
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FDA Review#
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