ACS:180 and Advia Centaur Ipth Immunoassay
FDA 510(k) K020217 · Bayer Diagnostics Corp.
510(k) numberK020217
Submission
- Device name
- ACS:180 and Advia Centaur Ipth Immunoassay
- Applicant
- Bayer Diagnostics Corp.
Tarrytown, NY, US - Received
- January 22, 2002
- Decision date
- March 15, 2002
- 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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| K023841 | Ammonia Assay for the Advia 1650JIF · Traditional | 12/24/2002SE |
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Questions and answers
When was ACS:180 and Advia Centaur Ipth Immunoassay cleared by the FDA?
ACS:180 and Advia Centaur Ipth Immunoassay (K020217) received a 510(k) decision of Substantially Equivalent on March 15, 2002, 52 days after the submission was received.
What is the product code of K020217?
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.