Vitros Immunodiagnostic Products Ferritin Reagent Pack (GEM.1340), Ferritin Calibrators (GEM.C340)
FDA 510(k) K973331 · Ortho-Clinical Diagnostics, Inc.
510(k) numberK973331
Submission
- Device name
- Vitros Immunodiagnostic Products Ferritin Reagent Pack (GEM.1340), Ferritin Calibrators (GEM.C340)
- Applicant
- Ortho-Clinical Diagnostics, Inc.
Rochester, NY, US - Received
- September 4, 1997
- Decision date
- October 22, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DBF – Ferritin, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5340
- Specialty
- Immunology
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| K171642 | Atellica IM Ferritin AssayDBF · Traditional | Siemens Healthcare Diagnostics, Inc. | 08/31/2017SE |
| K133083 | Diazyme Ferritin Assay, Diazyme Ferritin Calibrator Set, Diazyme Ferritin Control SetDBF · Traditional | Diazyme Laboratories | 06/24/2014SE |
| K121232 | K-Assay (R) Ferritin Reagent, K-Assay (R) Ferritin CalibratorDBF · Traditional | Kamiya Biomedical Company | 05/24/2012SE |
| K110736 | Advia Chemistry Ferritin (FRT) MethodDBF · Traditional | Siemens Healthcare Diagnostics, Inc. | 08/17/2011SE |
| K100538 | Tina-Quant Ferritin Gen. 4DBF · Traditional | Roche Diagnostics | 06/22/2010SE |
| K092505 | Beckman Coulter Ferritin Reagent, Model: OSR61203DBF · Traditional | Beckman Coulter, Inc. | 12/11/2009SE |
| K062746 | Ferritin-Latex, Models 1418-2070, 1418-0279DBF · Traditional | Medicon Hellas S.A | 11/20/2006SE |
| K053211 | Rdi Hsferritin KitDBF · Traditional | Reference Diagnostics, Inc. | 03/13/2006SE |
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| K252393 | VITROS Immunodiagnostic Products hs Troponin I Reagent PackMMI · Traditional | 10/29/2025SE |
| K241534 | VITROS Immunodiagnostic Products Syphilis Reagent PackLIP · Traditional | 08/28/2024SE |
| K233581 | VITROS Immunodiagnostic Products Total ß-hCG II Reagent PackDHA · Traditional | 05/08/2024SE |
| K221197 | VITROS Immunodiagnostic Products Intact PTH II Reagent PackCEW · Traditional | 09/05/2023SE |
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| K221355 | VITROS Immuodiagnostic Products CA 125 II Reagent PackLTK · Traditional | 12/12/2022SE |
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| K212648 | VITROS Immunodiagnostic Products CK-MB Reagent PackJHX · Traditional | 01/28/2022SE |
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Questions and answers
When was Vitros Immunodiagnostic Products Ferritin Reagent Pack (GEM.1340), Ferritin Calibrators (GEM.C340) cleared by the FDA?
Vitros Immunodiagnostic Products Ferritin Reagent Pack (GEM.1340), Ferritin Calibrators (GEM.C340) (K973331) received a 510(k) decision of Substantially Equivalent on October 22, 1997, 48 days after the submission was received.
What is the product code of K973331?
The FDA product code is DBF – Ferritin, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5340.