FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COAG-A-MATE 2001
K Number: K790323
·
Decision Mar 21, 1979
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
180
Applicant Total
39
Review Days
34
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Basic Information
- Device Name
- COAG-A-MATE 2001
- K Number
- K790323
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5425
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- General Diagnostics
- Date Received
- February 15, 1979
- Decision Date
- March 21, 1979
- Product Code
- JPA
- 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 |
|---|---|---|---|
| JPA | System, Multipurpose For In Vitro Coagulation Studies | FDA class 2 | Hematology |
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