FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ACON UTI URINARY TRACT INFECTION TEST STRIPS
K Number: K063295
·
Decision Oct 12, 2007
Classifications
1
FEI Numbers
83
Registration Numbers
83
Same Product Code
6
Applicant Total
85
Review Days
345
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Basic Information
- Device Name
- ACON UTI URINARY TRACT INFECTION TEST STRIPS
- K Number
- K063295
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.7675
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- ACON Laboratories, Inc.
- Date Received
- November 1, 2006
- Decision Date
- October 12, 2007
- Product Code
- LJX
- 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 |
|---|---|---|---|
| LJX | Test, Urine Leukocyte | FDA class 1 | Hematology |
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