Syva Advance TM Fluorometer
FDA 510(k) K813146 · Syva Co.
510(k) numberK813146
Submission
- Device name
- Syva Advance TM Fluorometer
- Applicant
- Syva Co.
Mchenry, IL, US - Received
- November 6, 1981
- Decision date
- November 27, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KHO – Fluorometer, For Clinical Use
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2560
- Specialty
- Clinical Chemistry
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Questions and answers
When was Syva Advance TM Fluorometer cleared by the FDA?
Syva Advance TM Fluorometer (K813146) received a 510(k) decision of Substantially Equivalent on November 27, 1981, 21 days after the submission was received.
What is the product code of K813146?
The FDA product code is KHO – Fluorometer, For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2560.