Quantex Ferritin
FDA 510(k) K040879 · Instrumentation Laboratory CO
510(k) numberK040879
Submission
- Device name
- Quantex Ferritin
- Applicant
- Instrumentation Laboratory CO
Bedford, MA, US - Received
- April 5, 2004
- Decision date
- May 10, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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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| 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 |
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| 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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Questions and answers
When was Quantex Ferritin cleared by the FDA?
Quantex Ferritin (K040879) received a 510(k) decision of Substantially Equivalent on May 10, 2004, 35 days after the submission was received.
What is the product code of K040879?
The FDA product code is DBF – Ferritin, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5340.