Olympus CRP Latex Immunoturbidimetric Reagent
FDA 510(k) K002918 · Olympus America, Inc.
510(k) numberK002918
Submission
- Device name
- Olympus CRP Latex Immunoturbidimetric Reagent
- Applicant
- Olympus America, Inc.
Irving, TX, US - Received
- September 19, 2000
- Decision date
- October 25, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DCN – System, Test, C-Reactive Protein
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5270
- Specialty
- Immunology
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Questions and answers
When was Olympus CRP Latex Immunoturbidimetric Reagent cleared by the FDA?
Olympus CRP Latex Immunoturbidimetric Reagent (K002918) received a 510(k) decision of Substantially Equivalent on October 25, 2000, 36 days after the submission was received.
What is the product code of K002918?
The FDA product code is DCN – System, Test, C-Reactive Protein, a Class II (moderate risk) device regulated under 21 CFR 866.5270.