FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ABNORMAL HEMOGLOBIN CONTROL
K Number: K802569
·
Decision Nov 12, 1980
Classifications
1
FEI Numbers
9
Registration Numbers
9
Same Product Code
38
Applicant Total
3
Review Days
26
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Basic Information
- Device Name
- ABNORMAL HEMOGLOBIN CONTROL
- K Number
- K802569
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7500
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Marilyn L. Amick
- Date Received
- October 17, 1980
- Decision Date
- November 12, 1980
- Product Code
- KHG
- 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 |
|---|---|---|---|
| KHG | Whole Blood Hemoglobin Determination | FDA class 2 | Hematology |
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