Vitros 5,1 FS Chemistry System with Engen Laboratory Automation System
FDA 510(k) K063144 · Ortho-Clinical Diagnostics, Inc.
510(k) numberK063144
Submission
- Device name
- Vitros 5,1 FS Chemistry System with Engen Laboratory Automation System
- Applicant
- Ortho-Clinical Diagnostics, Inc.
Rochester, NY, US - Received
- October 16, 2006
- Decision date
- November 13, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JJE – Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2160
- Specialty
- Clinical Chemistry
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Questions and answers
When was Vitros 5,1 FS Chemistry System with Engen Laboratory Automation System cleared by the FDA?
Vitros 5,1 FS Chemistry System with Engen Laboratory Automation System (K063144) received a 510(k) decision of Substantially Equivalent on November 13, 2006, 28 days after the submission was received.
What is the product code of K063144?
The FDA product code is JJE – Analyzer, Chemistry (Photometric, Discrete), For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2160.