Vitros Chemistry Products K+ Slides and Calibrator Kit 2
FDA 510(k) K073157 · Ortho-Clinical Diagnostics, Inc.
510(k) numberK073157
Submission
- Device name
- Vitros Chemistry Products K+ Slides and Calibrator Kit 2
- Applicant
- Ortho-Clinical Diagnostics, Inc.
Rochester, NY, US - Received
- November 8, 2007
- Decision date
- December 7, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CEM – Electrode, Ion Specific, Potassium
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1600
- Specialty
- Clinical Chemistry
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|---|---|---|---|
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| K121012 | Flexlab 3.6, Accelerator A3600CEM · Traditional | Inpeco S.P.A. | 08/31/2012SE |
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| K112995 | Gem Premier 4000CEM · Traditional | Instrumentation Laboratory CO | 05/03/2012SE |
| K110520 | Biolis 12ICEM · Traditional | Tokyo Boeki Medisys, Inc. | 03/23/2012SE |
| K112412 | AU5800(R) Chemistry AnalyzerCEM · Traditional | Beckman Coulter, Inc. | 12/23/2011SE |
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Questions and answers
When was Vitros Chemistry Products K+ Slides and Calibrator Kit 2 cleared by the FDA?
Vitros Chemistry Products K+ Slides and Calibrator Kit 2 (K073157) received a 510(k) decision of Substantially Equivalent on December 7, 2007, 29 days after the submission was received.
What is the product code of K073157?
The FDA product code is CEM – Electrode, Ion Specific, Potassium, a Class II (moderate risk) device regulated under 21 CFR 862.1600.