FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FLUOROMETER, GENERAL USE
K Number: K830624
·
Decision Apr 5, 1983
Classifications
1
FEI Numbers
51
Registration Numbers
51
Same Product Code
37
Applicant Total
28
Review Days
36
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Basic Information
- Device Name
- FLUOROMETER, GENERAL USE
- K Number
- K830624
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2560
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Abbott Diagnostics
- Date Received
- February 28, 1983
- Decision Date
- April 5, 1983
- Product Code
- KHO
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- TX
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KHO | Fluorometer, For Clinical Use | FDA class 1 | Clinical Chemistry |
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