Spectrofluorometer SF-330
FDA 510(k) K780362 · Varian Assoc., Inc.
510(k) numberK780362
Submission
- Device name
- Spectrofluorometer SF-330
- Applicant
- Varian Assoc., Inc.
Mchenry, IL, US - Received
- March 6, 1978
- Decision date
- March 22, 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 Spectrofluorometer SF-330 cleared by the FDA?
Spectrofluorometer SF-330 (K780362) received a 510(k) decision of Substantially Equivalent on March 22, 1978, 16 days after the submission was received.
What is the product code of K780362?
The FDA product code is KHO – Fluorometer, For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2560.