FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PLATELET CONTROL
K Number: K780980
·
Decision Jul 27, 1978
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
191
Applicant Total
25
Review Days
45
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Basic Information
- Device Name
- PLATELET CONTROL
- K Number
- K780980
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.8625
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Bhp Diagnostix, Inc.
- Date Received
- June 12, 1978
- Decision Date
- July 27, 1978
- Product Code
- JPK
- 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 |
|---|---|---|---|
| JPK | Mixture, Hematology Quality Control | FDA class 2 | Hematology |
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Other Clearances by Bhp Diagnostix, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K904503 | SERACON CR REFERENCE | Nov 2, 1990 | Substantially Equivalent |
| K863648 | SERACON CT REFERENCE | Oct 29, 1986 | Substantially Equivalent |
| K862594 | SERACON(TM) CAL (PRODUCT NO. DO35) | Aug 19, 1986 | Substantially Equivalent |
| K844927 | QUANTICEL HHR + TWO HUMAN HEMATOLOGY W/PLATELETS | Mar 22, 1985 | Substantially Equivalent |
| K844928 | QUANTICEL HHR TWO HUMAN HEMATOLOGY REFERENCE | Mar 22, 1985 | Substantially Equivalent |
| K844026 | SERACON TM SR IV | Nov 27, 1984 | Substantially Equivalent |
| K844027 | SERACON TM SR III | Nov 27, 1984 | Substantially Equivalent |
| K792486 | SERACON-SRI (PROD. # D029 | Dec 31, 1979 | Substantially Equivalent |
| K792487 | SERACON-SRII | Dec 31, 1979 | Substantially Equivalent |
| K792485 | SERACON-SRI | Dec 31, 1979 | Substantially Equivalent |