DIMENSION VISTA LOCI CA 19-9 FLEX REAGENT CARTRIDGE, AND DIMENSION LOCI7 CALIBRATOR WITH MODEL(S) K6457, AND KC604
FDA 510(k) clearance K100375 · decided 2011-04-06
Clearance details
- K-number
- K100375
- Device name
- DIMENSION VISTA LOCI CA 19-9 FLEX REAGENT CARTRIDGE, AND DIMENSION LOCI7 CALIBRATOR WITH MODEL(S) K6457, AND KC604
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-02-12
- Decision date
- 2011-04-06
- Days to decision
- 418 days
- Clearance type
- Traditional
- Product code
- NIG
- Device class
- 2
- Regulation number
- 866.6010
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Newark, DE, US
- Third-party review
- No
- Expedited review
- No
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| Lumpipulse G CA19-9-N (K191973) | Fujirebio Dianostics, Inc. | 2019-10-22 |
| 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.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| IMMULITE 2000 PSA (P930027/S039) | Siemens Healthcare Diagnostics, Inc. | 2026-07-27 |
| IMMULITE 2000 AFP (P010007/S026) | Siemens Healthcare Diagnostics, Inc. | 2026-07-27 |
| Atellica IM free PSA II (fPSAII) (P250026) | Siemens Healthcare Diagnostics, Inc. | 2026-05-11 |
| ADVIA Centaur AFP and Atellica IM Alpha Fetoprotein (AFP) (P930036/S026) | Siemens Healthcare Diagnostics, Inc. | 2026-05-11 |
| IMMULITE 2000 AFP (P010007/S025) | Siemens Healthcare Diagnostics, Inc. | 2026-04-21 |
| IMMULITE 2000 PSA (P930027/S038) | Siemens Healthcare Diagnostics, Inc. | 2026-04-21 |
| Atellica IM Total PSA II (tPSAII) (P240021) | Siemens Healthcare Diagnostics, Inc. | 2025-12-03 |
| IMMULITE 2000 PSA (P930027/S037) | Siemens Healthcare Diagnostics, Inc. | 2025-10-30 |