FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SERACON(TM) CAL (PRODUCT NO. DO35)
K Number: K862594
·
Decision Aug 19, 1986
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
301
Applicant Total
25
Review Days
42
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Basic Information
- Device Name
- SERACON(TM) CAL (PRODUCT NO. DO35)
- K Number
- K862594
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1150
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Bhp Diagnostix, Inc.
- Date Received
- July 8, 1986
- Decision Date
- August 19, 1986
- Product Code
- JIX
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| JIX | Calibrator, Multi-Analyte Mixture | FDA class 2 | Clinical Chemistry |
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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 |
| 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 |
| K791958 | SERACON - EL DO27 | Oct 17, 1979 | Substantially Equivalent |