FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COATEST FACTOR VIII
K Number: K833892
·
Decision Jan 30, 1984
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
189
Applicant Total
8
Review Days
82
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Basic Information
- Device Name
- COATEST FACTOR VIII
- K Number
- K833892
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7290
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Kabivitrum, Inc.
- Date Received
- November 9, 1983
- Decision Date
- January 30, 1984
- Product Code
- GGP
- 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 |
|---|---|---|---|
| GGP | Test, Qualitative And Quantitative Factor Deficiency | FDA class 2 | Hematology |
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Other Clearances by Kabivitrum, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K884058 | COATEST PROTEIN C | Dec 13, 1988 | Substantially Equivalent |
| K854572 | COATEST PLASMINOGEN | Feb 26, 1986 | 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 |
| K832114 | COATEST FACTOR X | Aug 26, 1983 | Substantially Equivalent |
| K812829 | COATEST ANTITHROMBIN | Dec 30, 1981 | Substantially Equivalent |