FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ACCESS HEMAWIPE
K Number: K843601
·
Decision Jan 4, 1985
Classifications
1
FEI Numbers
64
Registration Numbers
64
Same Product Code
96
Applicant Total
3
Review Days
114
Basic Information
- Device Name
- ACCESS HEMAWIPE
- K Number
- K843601
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.6550
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- MED TECH PRODUCTS, INC.
- Date Received
- September 12, 1984
- Decision Date
- January 4, 1985
- Product Code
- KHE
- 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 |
|---|---|---|---|
| KHE | Reagent, Occult Blood | FDA class 2 | Hematology |
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