FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HEMOGLOBIN CONTROLS
K Number: K790310
·
Decision Mar 21, 1979
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
14
Applicant Total
4
Review Days
36
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Basic Information
- Device Name
- HEMOGLOBIN CONTROLS
- K Number
- K790310
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.8625
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Electrophoresis Corp.
- Date Received
- February 13, 1979
- Decision Date
- March 21, 1979
- Product Code
- GGM
- 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 |
|---|---|---|---|
| GGM | Control, Hemoglobin | FDA class 2 | Hematology |
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