Access Afp QC on the Access Immunoassay Analyzer, Model Number 33219
FDA 510(k) K981864 · Beckman Coulter, Inc.
510(k) numberK981864
Submission
- Device name
- Access Afp QC on the Access Immunoassay Analyzer, Model Number 33219
- Applicant
- Beckman Coulter, Inc.
Chaska, MN, US - Received
- May 27, 1998
- Decision date
- June 12, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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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Questions and answers
When was Access Afp QC on the Access Immunoassay Analyzer, Model Number 33219 cleared by the FDA?
Access Afp QC on the Access Immunoassay Analyzer, Model Number 33219 (K981864) received a 510(k) decision of Substantially Equivalent on June 12, 1998, 16 days after the submission was received.
What is the product code of K981864?
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.