FDA 510(k)
FDA class 2
Substantially Equivalent
🇸🇪 Sweden
COAMATE PROTEIN C CHROMOGENIC ASSAY
K Number: K922201
·
Decision Dec 7, 1992
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
189
Applicant Total
4
Review Days
210
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Basic Information
- Device Name
- COAMATE PROTEIN C CHROMOGENIC ASSAY
- K Number
- K922201
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7290
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Chromogenix AB
- Date Received
- May 11, 1992
- Decision Date
- December 7, 1992
- Product Code
- GGP
- 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 |
|---|---|---|---|
| GGP | Test, Qualitative And Quantitative Factor Deficiency | FDA class 2 | Hematology |
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