Spectro Feiritin
FDA 510(k) K812056 · Ramco Laboratories, Inc.
510(k) numberK812056
Submission
- Device name
- Spectro Feiritin
- Applicant
- Ramco Laboratories, Inc.
Mchenry, IL, US - Received
- July 21, 1981
- Decision date
- August 12, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
More from Reference Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K983107 | VfeGGP · Traditional | 10/22/1998SE |
| K981208 | TFRJNM · Traditional | 10/21/1998SE |
| K910481 | Epo-RiaGGT · Traditional | 11/29/1991SE |
| K872941 | Spectro CGGP · Traditional | 09/04/1987SE |
| K864701 | VWF ImmunoblotGGP · Traditional | 03/30/1987SE |
| K861159 | Spectro VWFGGP · Traditional | 05/01/1986SE |
| K831470 | PTH MRCEW · Traditional | 06/22/1983SE |
| K823016 | Candida Detection SystemLHK · Traditional | 12/28/1982SE |
Questions and answers
When was Spectro Feiritin cleared by the FDA?
Spectro Feiritin (K812056) received a 510(k) decision of Substantially Equivalent on August 12, 1981, 22 days after the submission was received.
What is the product code of K812056?
The FDA product code is DBF – Ferritin, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5340.