FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COATEST APC (TM) RESISTANCE V/COATEST APC (TM) RESISTANCE V S
K Number: K963111
·
Decision Dec 23, 1996
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
31
Applicant Total
4
Review Days
133
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Basic Information
- Device Name
- COATEST APC (TM) RESISTANCE V/COATEST APC (TM) RESISTANCE V S
- K Number
- K963111
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7925
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Chromogenix AB
- Date Received
- August 12, 1996
- Decision Date
- December 23, 1996
- Product Code
- GGW
- 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 |
|---|---|---|---|
| GGW | Test, Time, Partial Thromboplastin | FDA class 2 | Hematology |
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