Vitros Chemistry Product Na+ Slides; Vitros Chemistry Products Calibrator Kit 2
FDA 510(k) K081411 · Ortho-Clinical Diagnostics, Inc.
510(k) numberK081411
Submission
- Device name
- Vitros Chemistry Product Na+ Slides; Vitros Chemistry Products Calibrator Kit 2
- Applicant
- Ortho-Clinical Diagnostics, Inc.
Rochester, NY, US - Received
- May 20, 2008
- Decision date
- June 30, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JGS – Electrode, Ion Specific, Sodium
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1665
- Specialty
- Clinical Chemistry
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| K183688 | i-STAT CHEM8+ cartridge with the i-STAT 1 SystemJGS · Traditional | Abbott Point of Care, Inc. | 02/07/2020SE |
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Questions and answers
When was Vitros Chemistry Product Na+ Slides; Vitros Chemistry Products Calibrator Kit 2 cleared by the FDA?
Vitros Chemistry Product Na+ Slides; Vitros Chemistry Products Calibrator Kit 2 (K081411) received a 510(k) decision of Substantially Equivalent on June 30, 2008, 41 days after the submission was received.
What is the product code of K081411?
The FDA product code is JGS – Electrode, Ion Specific, Sodium, a Class II (moderate risk) device regulated under 21 CFR 862.1665.