Vitros Immunodiagnostic Products Folate Reagent Pack 1/2, Vitros Immunodiagnostic Products Vitamin B12/FOLATE Reagent P3
FDA 510(k) K984166 · Ortho-Clinical Diagnostics, Inc.
510(k) numberK984166
Submission
- Device name
- Vitros Immunodiagnostic Products Folate Reagent Pack 1/2, Vitros Immunodiagnostic Products Vitamin B12/FOLATE Reagent P3
- Applicant
- Ortho-Clinical Diagnostics, Inc.
Rochester, NY, US - Received
- November 20, 1998
- Decision date
- February 5, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CGN – Acid, Folic, Radioimmunoassay
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1295
- Specialty
- Clinical Chemistry
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Questions and answers
When was Vitros Immunodiagnostic Products Folate Reagent Pack 1/2, Vitros Immunodiagnostic Products Vitamin B12/FOLATE Reagent P3 cleared by the FDA?
Vitros Immunodiagnostic Products Folate Reagent Pack 1/2, Vitros Immunodiagnostic Products Vitamin B12/FOLATE Reagent P3 (K984166) received a 510(k) decision of Substantially Equivalent on February 5, 1999, 77 days after the submission was received.
What is the product code of K984166?
The FDA product code is CGN – Acid, Folic, Radioimmunoassay, a Class II (moderate risk) device regulated under 21 CFR 862.1295.