FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
STONEGUARD II REAGENT STRIPS FOR URINALYSIS AND CONFIRM CONTROL SOLUTIONS
K Number: K030650
·
Decision Apr 14, 2003
Classifications
1
FEI Numbers
70
Registration Numbers
70
Same Product Code
10
Applicant Total
1
Review Days
45
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Basic Information
- Device Name
- STONEGUARD II REAGENT STRIPS FOR URINALYSIS AND CONFIRM CONTROL SOLUTIONS
- K Number
- K030650
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1550
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Uridynamics, Inc.
- Date Received
- February 28, 2003
- Decision Date
- April 14, 2003
- Product Code
- CEN
- 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 |
|---|---|---|---|
| CEN | Dye-Indicator, Ph (Urinary, Non-Quantitative) | FDA class 1 | Clinical Chemistry |
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