FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DEXPAD, BLOOD GLUCOSE STRIP
K Number: K880585
·
Decision Apr 18, 1988
Classifications
1
FEI Numbers
131
Registration Numbers
131
Same Product Code
400
Applicant Total
2
Review Days
68
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Basic Information
- Device Name
- DEXPAD, BLOOD GLUCOSE STRIP
- K Number
- K880585
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1345
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Mach Diag. C/O Wichita State University
- Date Received
- February 10, 1988
- Decision Date
- April 18, 1988
- Product Code
- CGA
- Advisory Committee
- Clinical Chemistry
- 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 |
|---|---|---|---|
| CGA | Glucose Oxidase, Glucose | FDA class 2 | Clinical Chemistry |
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Other Clearances by Mach Diag. C/O Wichita State University
| K Number | Device Name | ||
|---|---|---|---|
| K880584 | URI-CHEM(R) GK,2,3,4C,5CN,6C,7C AND 8C | May 31, 1988 | Substantially Equivalent |