FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HEMATIC BLOOD MIXER
K Number: K802608
·
Decision Dec 11, 1980
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
7
Applicant Total
3
Review Days
51
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Basic Information
- Device Name
- HEMATIC BLOOD MIXER
- K Number
- K802608
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.9195
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Helmer Labs, Inc.
- Date Received
- October 21, 1980
- Decision Date
- December 11, 1980
- Product Code
- KSQ
- 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 |
|---|---|---|---|
| KSQ | Device, Blood Mixing And Blood Weighing | FDA class 1 | Hematology |
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