Vitros Immunodiagnostic Products Folate Verifiers, Vitros Immunodiagnostic Products Vitamin B12 Range Verifiers
FDA 510(k) K990026 · Ortho-Clinical Diagnostics, Inc.
510(k) numberK990026
Submission
- Device name
- Vitros Immunodiagnostic Products Folate Verifiers, Vitros Immunodiagnostic Products Vitamin B12 Range Verifiers
- Applicant
- Ortho-Clinical Diagnostics, Inc.
Rochester, NY, US - Received
- January 5, 1999
- Decision date
- January 29, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JJX – Single (Specified) Analyte Controls (Assayed And Unassayed)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1660
- Specialty
- Clinical Chemistry
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Questions and answers
When was Vitros Immunodiagnostic Products Folate Verifiers, Vitros Immunodiagnostic Products Vitamin B12 Range Verifiers cleared by the FDA?
Vitros Immunodiagnostic Products Folate Verifiers, Vitros Immunodiagnostic Products Vitamin B12 Range Verifiers (K990026) received a 510(k) decision of Substantially Equivalent on January 29, 1999, 24 days after the submission was received.
What is the product code of K990026?
The FDA product code is JJX – Single (Specified) Analyte Controls (Assayed And Unassayed), a Class I (low risk) device regulated under 21 CFR 862.1660.