FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COATEST ANTITHROMBIN
K Number: K812829
·
Decision Dec 30, 1981
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
55
Applicant Total
8
Review Days
83
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Basic Information
- Device Name
- COATEST ANTITHROMBIN
- K Number
- K812829
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7060
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Kabivitrum, Inc.
- Date Received
- October 8, 1981
- Decision Date
- December 30, 1981
- Product Code
- JBQ
- 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 |
|---|---|---|---|
| JBQ | Antithrombin Iii Quantitation | FDA class 2 | Hematology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JBQ), ordered by most recent decision date.
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BIOPHEN ANTITHROMBIN 2.5, REFERENCE # 221102; BIOPHEN ANTITHROMBIN 5, REFERENCE # 221105
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·Hematology
HEMOSIL LIQUID ANTITHROMBIN XL
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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 |
| K833892 | COATEST FACTOR VIII | Jan 30, 1984 | Substantially Equivalent |
| K832114 | COATEST FACTOR X | Aug 26, 1983 | Substantially Equivalent |