FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DIAG. KIT FOR TOTAL ANTITHROMBIN III
K Number: K771669
·
Decision Nov 9, 1977
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
55
Applicant Total
883
Review Days
69
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Basic Information
- Device Name
- DIAG. KIT FOR TOTAL ANTITHROMBIN III
- K Number
- K771669
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7060
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Abbott Laboratories
- Date Received
- September 1, 1977
- Decision Date
- November 9, 1977
- 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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HEMOSIL LIQUID ANTITHROMBIN XL
FDA 510(k)
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