Dimension Vista Loci Ca 15-3 Flex Reagent Cartridge, Dimension Vista Loci 7 Calibrator, Models: K6456 and KC605
FDA 510(k) K100344 · Siemens Healthcare Diagnostics
510(k) numberK100344
Submission
- Device name
- Dimension Vista Loci Ca 15-3 Flex Reagent Cartridge, Dimension Vista Loci 7 Calibrator, Models: K6456 and KC605
- Applicant
- Siemens Healthcare Diagnostics
Newark, DE, US - Received
- February 5, 2010
- Decision date
- April 18, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MOI – System, Test, Immunological, Antigen, Tumor
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.6010
- Specialty
- Immunology
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| K042732 | Architect Ca 15-3 AssayMOI · Traditional | Fujirebio Diagnostics,Inc. | 12/22/2004SE |
| K033036 | BR Monitor and BR Monitor Calibrators on the Access Immunoassay Systems, Model 387620…MOI · Traditional | Beckman Coulter, Inc. | 02/03/2004SE |
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Questions and answers
When was Dimension Vista Loci Ca 15-3 Flex Reagent Cartridge, Dimension Vista Loci 7 Calibrator, Models: K6456 and KC605 cleared by the FDA?
Dimension Vista Loci Ca 15-3 Flex Reagent Cartridge, Dimension Vista Loci 7 Calibrator, Models: K6456 and KC605 (K100344) received a 510(k) decision of Substantially Equivalent on April 18, 2011, 437 days after the submission was received.
What is the product code of K100344?
The FDA product code is MOI – System, Test, Immunological, Antigen, Tumor, a Class II (moderate risk) device regulated under 21 CFR 866.6010.