FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ARACHIDONIC ACID
K Number: K811290
·
Decision Jul 27, 1981
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
11
Applicant Total
37
Review Days
77
Basic Information
- Device Name
- ARACHIDONIC ACID
- K Number
- K811290
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.6675
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- BIO/DATA CORP.
- Date Received
- May 11, 1981
- Decision Date
- July 27, 1981
- Product Code
- JBX
- Advisory Committee
- Hematology
- 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 |
|---|---|---|---|
| JBX | Aggregrometer, Platelet | 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 |