FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ROYCO MODEL 371 SUPER DILUTOR
K Number: K791644
·
Decision Sep 19, 1979
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
13
Applicant Total
4
Review Days
27
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Basic Information
- Device Name
- ROYCO MODEL 371 SUPER DILUTOR
- K Number
- K791644
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.5240
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Royco Instruments
- Date Received
- August 23, 1979
- Decision Date
- September 19, 1979
- Product Code
- GKH
- 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 |
|---|---|---|---|
| GKH | Apparatus, Automated Blood Cell Diluting | FDA class 1 | Hematology |
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