Vitros Chemistry Products Trfrn Reahent; Vitros Chemistry Products Calibrator Kit 20; Vitros Chemistry Products Protein
FDA 510(k) K042477 · Ortho-Clinical Diagnostics, Inc.
510(k) numberK042477
Submission
- Device name
- Vitros Chemistry Products Trfrn Reahent; Vitros Chemistry Products Calibrator Kit 20; Vitros Chemistry Products Protein
- Applicant
- Ortho-Clinical Diagnostics, Inc.
Rochester, NY, US - Received
- September 13, 2004
- Decision date
- November 19, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DDG – Transferrin, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5880
- Specialty
- Immunology
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Questions and answers
When was Vitros Chemistry Products Trfrn Reahent; Vitros Chemistry Products Calibrator Kit 20; Vitros Chemistry Products Protein cleared by the FDA?
Vitros Chemistry Products Trfrn Reahent; Vitros Chemistry Products Calibrator Kit 20; Vitros Chemistry Products Protein (K042477) received a 510(k) decision of Substantially Equivalent on November 19, 2004, 67 days after the submission was received.
What is the product code of K042477?
The FDA product code is DDG – Transferrin, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5880.