Access Folate Calibrators on the Access Immunoassay Systems Model A98033
FDA 510(k) K111952 · Beckman Coulter, Inc.
510(k) numberK111952
Submission
- Device name
- Access Folate Calibrators on the Access Immunoassay Systems Model A98033
- Applicant
- Beckman Coulter, Inc.
Chaska, MN, US - Received
- July 11, 2011
- Decision date
- August 19, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 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 Access Folate Calibrators on the Access Immunoassay Systems Model A98033 cleared by the FDA?
Access Folate Calibrators on the Access Immunoassay Systems Model A98033 (K111952) received a 510(k) decision of Substantially Equivalent on August 19, 2011, 39 days after the submission was received.
What is the product code of K111952?
The FDA product code is JIT – Calibrator, Secondary, a Class II (moderate risk) device regulated under 21 CFR 862.1150.