FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HEMOCUE HEMOLIN
K Number: K963908
·
Decision Oct 16, 1996
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
14
Applicant Total
5
Review Days
16
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Basic Information
- Device Name
- HEMOCUE HEMOLIN
- K Number
- K963908
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.8625
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Direct Solutions
- Date Received
- September 30, 1996
- Decision Date
- October 16, 1996
- 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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