Microfluor Reader
FDA 510(k) K822772 · Dynatech Corp.
510(k) numberK822772
Submission
- Device name
- Microfluor Reader
- Applicant
- Dynatech Corp.
Mchenry, IL, US - Received
- September 14, 1982
- Decision date
- October 27, 1982
- 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 Microfluor Reader cleared by the FDA?
Microfluor Reader (K822772) received a 510(k) decision of Substantially Equivalent on October 27, 1982, 43 days after the submission was received.
What is the product code of K822772?
The FDA product code is KHO – Fluorometer, For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2560.