Detector, Model LC-100 Fluorescence
FDA 510(k) K760261 · The Perkin-Elmer Corp.
510(k) numberK760261
Submission
- Device name
- Detector, Model LC-100 Fluorescence
- Applicant
- The Perkin-Elmer Corp.
Mchenry, IL, US - Received
- July 19, 1976
- Decision date
- September 27, 1976
- 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 Detector, Model LC-100 Fluorescence cleared by the FDA?
Detector, Model LC-100 Fluorescence (K760261) received a 510(k) decision of Substantially Equivalent on September 27, 1976, 70 days after the submission was received.
What is the product code of K760261?
The FDA product code is KHO – Fluorometer, For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2560.