Advia Centaur and Acs: 180 Folate Immunoassay
FDA 510(k) K010050 · Bayer Diagnostics Corp.
510(k) numberK010050
Submission
- Device name
- Advia Centaur and Acs: 180 Folate Immunoassay
- Applicant
- Bayer Diagnostics Corp.
Medfield, MA, US - Received
- January 5, 2001
- Decision date
- February 5, 2001
- 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 Advia Centaur and Acs: 180 Folate Immunoassay cleared by the FDA?
Advia Centaur and Acs: 180 Folate Immunoassay (K010050) received a 510(k) decision of Substantially Equivalent on February 5, 2001, 31 days after the submission was received.
What is the product code of K010050?
The FDA product code is CGN – Acid, Folic, Radioimmunoassay, a Class II (moderate risk) device regulated under 21 CFR 862.1295.