FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FECAL OCCULT SLIDE TEST KIT
K Number: K830223
·
Decision Mar 7, 1983
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
96
Applicant Total
4
Review Days
42
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Basic Information
- Device Name
- FECAL OCCULT SLIDE TEST KIT
- K Number
- K830223
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.6550
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Cambridge Chemical Products, Inc.
- Date Received
- January 24, 1983
- Decision Date
- March 7, 1983
- Product Code
- KHE
- Advisory Committee
- Hematology
- Review Advisory Committee
- CH
- 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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