Auto Carouse/Wash Solution Concentrate
FDA 510(k) K831518 · Syva Co.
510(k) numberK831518
Submission
- Device name
- Auto Carouse/Wash Solution Concentrate
- Applicant
- Syva Co.
Mchenry, IL, US - Received
- May 12, 1983
- Decision date
- June 22, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 Auto Carouse/Wash Solution Concentrate cleared by the FDA?
Auto Carouse/Wash Solution Concentrate (K831518) received a 510(k) decision of Substantially Equivalent on June 22, 1983, 41 days after the submission was received.
What is the product code of K831518?
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.