Immage Immunochemistry System Ferritin (Fer)Reagent, Immage Immunochemistry System Ferritin Calibrator
FDA 510(k) K983340 · Beckman Coulter, Inc.
510(k) numberK983340
Submission
- Device name
- Immage Immunochemistry System Ferritin (Fer)Reagent, Immage Immunochemistry System Ferritin Calibrator
- Applicant
- Beckman Coulter, Inc.
Brea, CA, US - Received
- September 23, 1998
- Decision date
- December 14, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 Immage Immunochemistry System Ferritin (Fer)Reagent, Immage Immunochemistry System Ferritin Calibrator cleared by the FDA?
Immage Immunochemistry System Ferritin (Fer)Reagent, Immage Immunochemistry System Ferritin Calibrator (K983340) received a 510(k) decision of Substantially Equivalent on December 14, 1998, 82 days after the submission was received.
What is the product code of K983340?
The FDA product code is DBF – Ferritin, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5340.