Olympus Ferritin Immunoturbidimetric Reagent
FDA 510(k) K963170 · Olympus America, Inc.
510(k) numberK963170
Submission
- Device name
- Olympus Ferritin Immunoturbidimetric Reagent
- Applicant
- Olympus America, Inc.
Melville, NY, US - Received
- August 14, 1996
- Decision date
- December 2, 1996
- 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 Olympus Ferritin Immunoturbidimetric Reagent cleared by the FDA?
Olympus Ferritin Immunoturbidimetric Reagent (K963170) received a 510(k) decision of Substantially Equivalent on December 2, 1996, 110 days after the submission was received.
What is the product code of K963170?
The FDA product code is DBF – Ferritin, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5340.