FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PLATELET AGITATOR
K Number: K812533
·
Decision Sep 29, 1981
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
7
Applicant Total
3
Review Days
27
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Basic Information
- Device Name
- PLATELET AGITATOR
- K Number
- K812533
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.9195
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Helmer Labs, Inc.
- Date Received
- September 2, 1981
- Decision Date
- September 29, 1981
- 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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