FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
COATEST PLASMINOGEN
K Number: K854572
·
Decision Feb 26, 1986
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
9
Applicant Total
8
Review Days
104
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Basic Information
- Device Name
- COATEST PLASMINOGEN
- K Number
- K854572
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.5715
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Kabivitrum, Inc.
- Date Received
- November 14, 1985
- Decision Date
- February 26, 1986
- Product Code
- DDX
- Advisory Committee
- Immunology
- 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 |
|---|---|---|---|
| DDX | Plasminogen, Antigen, Antiserum, Control | FDA class 1 | Immunology |
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Other Clearances by Kabivitrum, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K884058 | COATEST PROTEIN C | Dec 13, 1988 | Substantially Equivalent |
| K844664 | THE I.V. BAG | May 6, 1985 | Substantially Equivalent |
| K833890 | COATEST ANTIPLASMIN | Jan 30, 1984 | Substantially Equivalent |
| K833891 | COATEST HEPARIN | Jan 30, 1984 | Substantially Equivalent |
| K833892 | COATEST FACTOR VIII | Jan 30, 1984 | Substantially Equivalent |
| K832114 | COATEST FACTOR X | Aug 26, 1983 | Substantially Equivalent |
| K812829 | COATEST ANTITHROMBIN | Dec 30, 1981 | Substantially Equivalent |