Olympus Igg Immunoturbidimetric Reagent
FDA 510(k) K951013 · Olympus America, Inc.
510(k) numberK951013
Submission
- Device name
- Olympus Igg Immunoturbidimetric Reagent
- Applicant
- Olympus America, Inc.
Lake Success, NY, US - Received
- March 6, 1995
- Decision date
- April 17, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- CFQ – Radioimmunoassay, Immunoglobulins (G, A, M)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5510
- Specialty
- Immunology
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Questions and answers
When was Olympus Igg Immunoturbidimetric Reagent cleared by the FDA?
Olympus Igg Immunoturbidimetric Reagent (K951013) received a 510(k) decision of Substantially Equivalent on April 17, 1995, 42 days after the submission was received.
What is the product code of K951013?
The FDA product code is CFQ – Radioimmunoassay, Immunoglobulins (G, A, M), a Class II (moderate risk) device regulated under 21 CFR 866.5510.