FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HEALTHTEST HEPARIN/PLATELET FACTOR 4 ANTIBODY ASSAY
K Number: K040293
·
Decision May 28, 2004
Classifications
1
FEI Numbers
7
Registration Numbers
7
Same Product Code
12
Applicant Total
3
Review Days
112
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Basic Information
- Device Name
- HEALTHTEST HEPARIN/PLATELET FACTOR 4 ANTIBODY ASSAY
- K Number
- K040293
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7695
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Akers Laboratories, Inc.
- Date Received
- February 6, 2004
- Decision Date
- May 28, 2004
- Product Code
- LCO
- 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 |
|---|---|---|---|
| LCO | Platelet Factor 4 Radioimmunoassay | FDA class 2 | Hematology |
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