FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
THE I.V. BAG
K Number: K844664
·
Decision May 6, 1985
Classifications
1
FEI Numbers
86
Registration Numbers
86
Same Product Code
116
Applicant Total
8
Review Days
157
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Basic Information
- Device Name
- THE I.V. BAG
- K Number
- K844664
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5025
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Kabivitrum, Inc.
- Date Received
- November 30, 1984
- Decision Date
- May 6, 1985
- Product Code
- KPE
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| KPE | Container, I.V. | FDA class 2 | General Hospital |
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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 |
| 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 |