Spectrophotometer Model 650-40
FDA 510(k) K790236 · The Perkin-Elmer Corp.
510(k) numberK790236
Submission
- Device name
- Spectrophotometer Model 650-40
- Applicant
- The Perkin-Elmer Corp.
Mchenry, IL, US - Received
- February 1, 1979
- Decision date
- March 15, 1979
- 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 Spectrophotometer Model 650-40 cleared by the FDA?
Spectrophotometer Model 650-40 (K790236) received a 510(k) decision of Substantially Equivalent on March 15, 1979, 42 days after the submission was received.
What is the product code of K790236?
The FDA product code is KHO – Fluorometer, For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2560.