Lumipulse G CA19-9-N
FDA 510(k) clearance K200997 · decided 2020-05-14
Clearance details
- K-number
- K200997
- Device name
- Lumipulse G CA19-9-N
- Applicant
- Fujirebio Diagnostics,Inc.
- Decision
- Substantially Equivalent
- Date received
- 2020-04-16
- Decision date
- 2020-05-14
- Days to decision
- 28 days
- Clearance type
- Special
- Product code
- NIG
- Device class
- 2
- Regulation number
- 866.6010
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Malvern, PA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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|---|---|---|
| VITROS Immunodiagnostic Products CA 19-9TM Reagent Pack (K231525) | Ortho Clinical Diagnostics | 2023-08-09 |
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| 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 |
| BAYER ADVIA CENTAUR CA 19-9 ASSAY (K031393) | Bayer Healthcare, LLC | 2003-06-24 |
| 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
No recalls on record reference this clearance.