Advia Centaur Vitamin B12 Master Curve Material, Total HCG Master Curve Material, and Testosterone Master Curve Material
FDA 510(k) K140505 · Siemens Healthcare Diagnostics, Inc.
510(k) numberK140505
Submission
- Device name
- Advia Centaur Vitamin B12 Master Curve Material, Total HCG Master Curve Material, and Testosterone Master Curve Material
- Applicant
- Siemens Healthcare Diagnostics, Inc.
Tarrytown, NY, US - Received
- February 27, 2014
- Decision date
- March 31, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 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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| K161522 | LIAISON EBV IgM Serum Control SetJJX · Special | DiaSorin, Inc. | 06/30/2016SE |
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| K151742 | Contour Next Control SolutionJJX · Traditional | Bayer Healthcare | 09/23/2015SE |
| K143687 | ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Centaur…JJX · Traditional | Siemens Healthcare Diagnostics, Inc. | 07/17/2015SE |
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Questions and answers
When was Advia Centaur Vitamin B12 Master Curve Material, Total HCG Master Curve Material, and Testosterone Master Curve Material cleared by the FDA?
Advia Centaur Vitamin B12 Master Curve Material, Total HCG Master Curve Material, and Testosterone Master Curve Material (K140505) received a 510(k) decision of Substantially Equivalent on March 31, 2014, 32 days after the submission was received.
What is the product code of K140505?
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.