Nordiclab Ferritin Irma Test
FDA 510(k) K801989 · Nordiclab Intl.
510(k) numberK801989
Submission
- Device name
- Nordiclab Ferritin Irma Test
- Applicant
- Nordiclab Intl.
Mchenry, IL, US - Received
- August 19, 1980
- Decision date
- September 16, 1980
- 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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|---|---|---|---|
| K193650 | LIAISON FerritinDBF · Traditional | DiaSorin, Inc. | 09/14/2021SE |
| K191562 | Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid FactorDBF · Traditional | Horiba Abx SAS | 03/06/2020SE |
| 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 |
|---|---|---|
| K801988 | Nordiclab Prostatic Acid Phosphatase RiaJFH · Traditional | 09/26/1980SE |
| K800922 | Nordiclab Progesterone Ria TestJLS · Traditional | 05/14/1980SE |
| K800921 | Nordiclab Testosterone Ria TestCDZ · Traditional | 05/14/1980SE |
| K800920 | Nordiclab Estradiol Ria TestCHP · Traditional | 05/14/1980SE |
| K792189 | Nordiclab Total Estriol Ria TestCGI · Traditional | 11/13/1979SE |
| K782157 | Irma Test, Nordiclab FerritinJMG · Traditional | 01/17/1979SE |
| K782099 | Ria Test, Nordicalb HPLJMF · Traditional | 01/10/1979SE |
Questions and answers
When was Nordiclab Ferritin Irma Test cleared by the FDA?
Nordiclab Ferritin Irma Test (K801989) received a 510(k) decision of Substantially Equivalent on September 16, 1980, 28 days after the submission was received.
What is the product code of K801989?
The FDA product code is DBF – Ferritin, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5340.