Olympus Igg Reagent
FDA 510(k) K073490 · Olympus America, Inc.
510(k) numberK073490
Submission
- Device name
- Olympus Igg Reagent
- Applicant
- Olympus America, Inc.
Co. Clare, IE - Received
- December 12, 2007
- Decision date
- February 11, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CFN – Method, Nephelometric, 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 Reagent cleared by the FDA?
Olympus Igg Reagent (K073490) received a 510(k) decision of Substantially Equivalent on February 11, 2008, 61 days after the submission was received.
What is the product code of K073490?
The FDA product code is CFN – Method, Nephelometric, Immunoglobulins (G, A, M), a Class II (moderate risk) device regulated under 21 CFR 866.5510.