PFI-20 Polarizing Fluorimeter
FDA 510(k) K871550 · The Perkin-Elmer Corp.
510(k) numberK871550
Submission
- Device name
- PFI-20 Polarizing Fluorimeter
- Applicant
- The Perkin-Elmer Corp.
Norwalk, CT, US - Received
- April 22, 1987
- Decision date
- July 1, 1987
- 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 PFI-20 Polarizing Fluorimeter cleared by the FDA?
PFI-20 Polarizing Fluorimeter (K871550) received a 510(k) decision of Substantially Equivalent on July 1, 1987, 70 days after the submission was received.
What is the product code of K871550?
The FDA product code is KHO – Fluorometer, For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2560.