Beckman Coulter Ferritin Reagent, Model: OSR61203
FDA 510(k) K092505 · Beckman Coulter, Inc.
510(k) numberK092505
Submission
- Device name
- Beckman Coulter Ferritin Reagent, Model: OSR61203
- Applicant
- Beckman Coulter, Inc.
Co. Clare, IE - Received
- August 14, 2009
- Decision date
- December 11, 2009
- 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 Beckman Coulter Ferritin Reagent, Model: OSR61203 cleared by the FDA?
Beckman Coulter Ferritin Reagent, Model: OSR61203 (K092505) received a 510(k) decision of Substantially Equivalent on December 11, 2009, 119 days after the submission was received.
What is the product code of K092505?
The FDA product code is DBF – Ferritin, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5340.