FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ABBOTT TESTPACK(TM) D-DIMER
K Number: K890422
·
Decision Mar 27, 1989
Classifications
1
FEI Numbers
22
Registration Numbers
22
Same Product Code
27
Applicant Total
883
Review Days
60
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Basic Information
- Device Name
- ABBOTT TESTPACK(TM) D-DIMER
- K Number
- K890422
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7320
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Abbott Laboratories
- Date Received
- January 26, 1989
- Decision Date
- March 27, 1989
- Product Code
- GHH
- 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 |
|---|---|---|---|
| GHH | Fibrin Split Products | FDA class 2 | Hematology |
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