FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PLASMA POOLER HEAT SEALER
K Number: K820301
·
Decision Apr 9, 1982
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
0
Applicant Total
6
Review Days
64
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Basic Information
- Device Name
- PLASMA POOLER HEAT SEALER
- K Number
- K820301
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.9750
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- North American Biologicals, Inc.
- Date Received
- February 4, 1982
- Decision Date
- April 9, 1982
- Product Code
- KSD
- 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 |
|---|---|---|---|
| KSD | Device, Heat-Sealing | FDA class 1 | Hematology |
Other Clearances by North American Biologicals, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K801219 | PLASMAPOOLER | Oct 31, 1980 | Substantially Equivalent |
| K801425 | RH CONTROL | Jul 14, 1980 | Substantially Equivalent |
| K781895 | BLOOD GROUP SUBSTANCE B | Dec 20, 1978 | Substantially Equivalent |
| K781862 | BLOOD GROUP SUBSTANCE A | Dec 20, 1978 | Substantially Equivalent |
| K781896 | BLOOD GROUP SUBSTANCE A,B | Dec 20, 1978 | Substantially Equivalent |