Diazyme Ferritin Assay, Diazyme Ferritin Calibrator Set, Diazyme Ferritin Control Set
FDA 510(k) K133083 · Diazyme Laboratories
510(k) numberK133083
Submission
- Device name
- Diazyme Ferritin Assay, Diazyme Ferritin Calibrator Set, Diazyme Ferritin Control Set
- Applicant
- Diazyme Laboratories
Poway, CA, US - Received
- September 30, 2013
- Decision date
- June 24, 2014
- 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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Questions and answers
When was Diazyme Ferritin Assay, Diazyme Ferritin Calibrator Set, Diazyme Ferritin Control Set cleared by the FDA?
Diazyme Ferritin Assay, Diazyme Ferritin Calibrator Set, Diazyme Ferritin Control Set (K133083) received a 510(k) decision of Substantially Equivalent on June 24, 2014, 267 days after the submission was received.
What is the product code of K133083?
The FDA product code is DBF – Ferritin, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5340.