FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CITREX II
K Number: K853077
·
Decision Aug 12, 1985
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
180
Applicant Total
37
Review Days
20
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Basic Information
- Device Name
- CITREX II
- K Number
- K853077
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5425
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Bio/Data Corp.
- Date Received
- July 23, 1985
- Decision Date
- August 12, 1985
- Product Code
- JPA
- 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 |
|---|---|---|---|
| JPA | System, Multipurpose For In Vitro Coagulation Studies | FDA class 2 | Hematology |
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Other Clearances by Bio/Data Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K001891 | MICROSAMPLE COAGULATION ANALYZER, MODEL MCA 310-C | Jul 12, 2000 | Substantially Equivalent |
| K943153 | MICROSAMPLE COAGULATION ANALYZER | Mar 24, 1995 | Substantially Equivalent |
| K893650 | PLATELET AGGREGATION PROFILER MODEL PAP-4C | Jun 23, 1989 | Substantially Equivalent |
| K881150 | KINETIC FIBRINOGEN ASSAY | Mar 28, 1988 | Substantially Equivalent |
| K873382 | PLATELET EXTRACT REAGENT | Nov 20, 1987 | Substantially Equivalent |
| K860751 | VON WILLEBRAND FAC. DEFIC. ABNORMAL CONTROL PLASMA | Mar 18, 1986 | Substantially Equivalent |
| K860342 | MICROSAMPLE COAGULATION ANALYSER, MODEL 110WP | Mar 4, 1986 | Substantially Equivalent |
| K854546 | MICROSAMPLE COAGULATION ANALYSER MODEL 110P | Jan 7, 1986 | Substantially Equivalent |
| K853897 | CITREX H | Oct 10, 1985 | Substantially Equivalent |
| K853246 | CALCIUM CHLORIDE | Aug 13, 1985 | Substantially Equivalent |