FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COAG-A-MATE(R) XC
K Number: K870960
·
Decision Mar 17, 1987
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
180
Applicant Total
130
Review Days
7
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Basic Information
- Device Name
- COAG-A-MATE(R) XC
- K Number
- K870960
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5425
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Organon Teknika Corp.
- Date Received
- March 10, 1987
- Decision Date
- March 17, 1987
- 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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