VITROS XT Chemistry Products GLU-Ca Slides
FDA 510(k) K190520 · Ortho-Clinical Diagnostics, Inc.
510(k) numberK190520
Submission
- Device name
- VITROS XT Chemistry Products GLU-Ca Slides
- Applicant
- Ortho-Clinical Diagnostics, Inc.
Rochester, NY, US - Received
- March 4, 2019
- Decision date
- April 3, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CGA – Glucose Oxidase, Glucose
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1345
- Specialty
- Clinical Chemistry
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Questions and answers
When was VITROS XT Chemistry Products GLU-Ca Slides cleared by the FDA?
VITROS XT Chemistry Products GLU-Ca Slides (K190520) received a 510(k) decision of Substantially Equivalent on April 3, 2019, 30 days after the submission was received.
What is the product code of K190520?
The FDA product code is CGA – Glucose Oxidase, Glucose, a Class II (moderate risk) device regulated under 21 CFR 862.1345.