Advia Centaur and ACS:180 C-Peptide Calibrator
FDA 510(k) K021532 · Bayer Diagnostics Corp.
510(k) numberK021532
Submission
- Device name
- Advia Centaur and ACS:180 C-Peptide Calibrator
- Applicant
- Bayer Diagnostics Corp.
Tarrytown, NY, US - Received
- May 10, 2002
- Decision date
- June 27, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JIT – Calibrator, Secondary
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1150
- Specialty
- Clinical Chemistry
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Questions and answers
When was Advia Centaur and ACS:180 C-Peptide Calibrator cleared by the FDA?
Advia Centaur and ACS:180 C-Peptide Calibrator (K021532) received a 510(k) decision of Substantially Equivalent on June 27, 2002, 48 days after the submission was received.
What is the product code of K021532?
The FDA product code is JIT – Calibrator, Secondary, a Class II (moderate risk) device regulated under 21 CFR 862.1150.