Aia-Pack Fer Calibration Verification Test Set
FDA 510(k) K924858 · Tosoh Medics, Inc.
510(k) numberK924858
Submission
- Device name
- Aia-Pack Fer Calibration Verification Test Set
- Applicant
- Tosoh Medics, Inc.
South San Francisco, CA, US - Received
- September 28, 1992
- Decision date
- December 15, 1992
- 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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| 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 |
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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 |
More from Reference Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K023893 | ST Aia-Pack Cea Enzyme ImmunoassayDHX · Special | 12/18/2002SE |
| K023894 | ST Aia-Pack Afp Enzyme ImmunoassayLOJ · Special | 12/17/2002SE |
| K023091 | ST Aia-Pack Testosterone AssayCDZ · Traditional | 12/17/2002SE |
| K023891 | ST Aia-Pack Ca 125 Enzyme ImmunoassayLTK · Special | 12/06/2002SE |
| K020489 | G7 Automated HPLC Analyzer, Beta-Thalassemia ModeJPD · Traditional | 05/14/2002SE |
| K012820 | Aia-Pack Ctni 2ND-GEN AssayMMI · Traditional | 12/14/2001SE |
| K011434 | G7 Automated HPLC AnalyzerLCP · Traditional | 09/18/2001SE |
| K010796 | Aia-Pack Brca, ST Aia Pack BrcaMOI · Traditional | 08/16/2001SE |
| K992365 | Aia-Pack Folate AssayCGN · Traditional | 08/10/1999SE |
| K990431 | Aia-Pack Ca 125LTK · Traditional | 06/03/1999SE |
Questions and answers
When was Aia-Pack Fer Calibration Verification Test Set cleared by the FDA?
Aia-Pack Fer Calibration Verification Test Set (K924858) received a 510(k) decision of Substantially Equivalent on December 15, 1992, 78 days after the submission was received.
What is the product code of K924858?
The FDA product code is DBF – Ferritin, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5340.