Vitros Chemistry Products Igg, Iga and Igm Reagents; Vitros Chemistry Product Calibrator Kit 20; Vitros Chemistry Produc
FDA 510(k) K042475 · Ortho-Clinical Diagnostics, Inc.
510(k) numberK042475
Submission
- Device name
- Vitros Chemistry Products Igg, Iga and Igm Reagents; Vitros Chemistry Product Calibrator Kit 20; Vitros Chemistry Produc
- Applicant
- Ortho-Clinical Diagnostics, Inc.
Rochester, NY, US - Received
- September 13, 2004
- Decision date
- November 10, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CFN – Method, Nephelometric, Immunoglobulins (G, A, M)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5510
- Specialty
- Immunology
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| K191465 | Human IgM Kit for use on SPAPlusCFN · Special | The Binding Site Group , Ltd. | 06/27/2019SE |
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| K183151 | Optilite IgA CSF KitCFN · Traditional | The Binding Site Group , Ltd. | 01/23/2019SE |
| K162208 | DxC 700 AU Clinical Chemistry Analyzer, AU IgG ReagentCFN · Traditional | Beckman Coulter, Inc. | 01/09/2017SE |
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Questions and answers
When was Vitros Chemistry Products Igg, Iga and Igm Reagents; Vitros Chemistry Product Calibrator Kit 20; Vitros Chemistry Produc cleared by the FDA?
Vitros Chemistry Products Igg, Iga and Igm Reagents; Vitros Chemistry Product Calibrator Kit 20; Vitros Chemistry Produc (K042475) received a 510(k) decision of Substantially Equivalent on November 10, 2004, 58 days after the submission was received.
What is the product code of K042475?
The FDA product code is CFN – Method, Nephelometric, Immunoglobulins (G, A, M), a Class II (moderate risk) device regulated under 21 CFR 866.5510.