FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DIA STRIPS SYSTEM, MODIFIED
K Number: K921495
·
Decision Jul 21, 1992
Classifications
1
FEI Numbers
46
Registration Numbers
46
Same Product Code
10
Applicant Total
1
Review Days
137
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Basic Information
- Device Name
- DIA STRIPS SYSTEM, MODIFIED
- K Number
- K921495
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.6550
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Symcon Intl., Inc.
- Date Received
- March 6, 1992
- Decision Date
- July 21, 1992
- Product Code
- JIO
- 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 |
|---|---|---|---|
| JIO | Blood, Occult, Colorimetric, In Urine | FDA class 2 | Hematology |
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