Vista Immunoassay System -- Modification
FDA 510(k) K922139 · Syva Co.
510(k) numberK922139
Submission
- Device name
- Vista Immunoassay System -- Modification
- Applicant
- Syva Co.
San Jose, CA, US - Received
- April 16, 1992
- Decision date
- July 21, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JJE – Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2160
- Specialty
- Clinical Chemistry
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Questions and answers
When was Vista Immunoassay System -- Modification cleared by the FDA?
Vista Immunoassay System -- Modification (K922139) received a 510(k) decision of Substantially Equivalent on July 21, 1992, 96 days after the submission was received.
What is the product code of K922139?
The FDA product code is JJE – Analyzer, Chemistry (Photometric, Discrete), For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2160.