Fluorescence Detector Model 420
FDA 510(k) K780031 · Waters Assoc., Inc.
510(k) numberK780031
Submission
- Device name
- Fluorescence Detector Model 420
- Applicant
- Waters Assoc., Inc.
Mchenry, IL, US - Received
- January 9, 1978
- Decision date
- January 20, 1978
- 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 Fluorescence Detector Model 420 cleared by the FDA?
Fluorescence Detector Model 420 (K780031) received a 510(k) decision of Substantially Equivalent on January 20, 1978, 11 days after the submission was received.
What is the product code of K780031?
The FDA product code is KHO – Fluorometer, For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2560.