FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SERACON CR REFERENCE
K Number: K904503
·
Decision Nov 2, 1990
Classifications
1
FEI Numbers
269
Registration Numbers
269
Same Product Code
492
Applicant Total
25
Review Days
31
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Basic Information
- Device Name
- SERACON CR REFERENCE
- K Number
- K904503
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1660
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Bhp Diagnostix, Inc.
- Date Received
- October 2, 1990
- Decision Date
- November 2, 1990
- Product Code
- JJX
- 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 |
|---|---|---|---|
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | FDA class 1 | Clinical Chemistry |
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Other Clearances by Bhp Diagnostix, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K791958 | SERACON - EL DO27 | Oct 17, 1979 | Substantially Equivalent |