Fluorostat Fluorometer
FDA 510(k) K822701 · Miles Laboratories, Inc.
510(k) numberK822701
Submission
- Device name
- Fluorostat Fluorometer
- Applicant
- Miles Laboratories, Inc.
Mchenry, IL, US - Received
- September 7, 1982
- Decision date
- October 8, 1982
- 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 Fluorostat Fluorometer cleared by the FDA?
Fluorostat Fluorometer (K822701) received a 510(k) decision of Substantially Equivalent on October 8, 1982, 31 days after the submission was received.
What is the product code of K822701?
The FDA product code is KHO – Fluorometer, For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2560.