FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DILUENT
K Number: K831617
·
Decision Jun 16, 1983
Classifications
1
FEI Numbers
54
Registration Numbers
54
Same Product Code
37
Applicant Total
5
Review Days
28
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Basic Information
- Device Name
- DILUENT
- K Number
- K831617
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.8200
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Omega Medical Diagnostics
- Date Received
- May 19, 1983
- Decision Date
- June 16, 1983
- Product Code
- GIF
- Advisory Committee
- Hematology
- Review Advisory Committee
- HE
- 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 |
|---|---|---|---|
| GIF | Diluent, Blood Cell | FDA class 1 | Hematology |
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