FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFIED EZ DETECT OCCULT BLOOD TEST IN STOOL
K Number: K860028
·
Decision Apr 7, 1986
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
96
Applicant Total
3
Review Days
94
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Basic Information
- Device Name
- MODIFIED EZ DETECT OCCULT BLOOD TEST IN STOOL
- K Number
- K860028
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.6550
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Self Care Systems, Inc.
- Date Received
- January 3, 1986
- Decision Date
- April 7, 1986
- 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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