Access STFR, Access STFR Calibrators, and Access STFR QC with Models, A32493, A32494, and A32495
FDA 510(k) K080634 · Beckman Coulter, Inc.
510(k) numberK080634
Submission
- Device name
- Access STFR, Access STFR Calibrators, and Access STFR QC with Models, A32493, A32494, and A32495
- Applicant
- Beckman Coulter, Inc.
Chaska, MN, US - Received
- March 6, 2008
- Decision date
- August 11, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DDG – Transferrin, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5880
- Specialty
- Immunology
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Questions and answers
When was Access STFR, Access STFR Calibrators, and Access STFR QC with Models, A32493, A32494, and A32495 cleared by the FDA?
Access STFR, Access STFR Calibrators, and Access STFR QC with Models, A32493, A32494, and A32495 (K080634) received a 510(k) decision of Substantially Equivalent on August 11, 2008, 158 days after the submission was received.
What is the product code of K080634?
The FDA product code is DDG – Transferrin, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5880.