The Vitros 5,1 FS Chemistry System
FDA 510(k) K041764 · Ortho-Clinical Diagnostics
510(k) numberK041764
Submission
- Device name
- The Vitros 5,1 FS Chemistry System
- Applicant
- Ortho-Clinical Diagnostics
Rochester, NY, US - Received
- June 30, 2004
- Decision date
- September 9, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LCP – Assay, Glycosylated Hemoglobin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7470
- Specialty
- Hematology
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| K180509 | Quo-Test A1c SystemLCP · Dual Track | Ekf-Diagnostic GmbH | 02/16/2019SE |
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Questions and answers
When was The Vitros 5,1 FS Chemistry System cleared by the FDA?
The Vitros 5,1 FS Chemistry System (K041764) received a 510(k) decision of Substantially Equivalent on September 9, 2004, 71 days after the submission was received.
What is the product code of K041764?
The FDA product code is LCP – Assay, Glycosylated Hemoglobin, a Class II (moderate risk) device regulated under 21 CFR 864.7470.