FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
URITEST 10 URINALYSIS REAGENT STRIPS
K Number: K052719
·
Decision Dec 5, 2006
Classifications
1
FEI Numbers
61
Registration Numbers
61
Same Product Code
8
Applicant Total
3
Review Days
432
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Basic Information
- Device Name
- URITEST 10 URINALYSIS REAGENT STRIPS
- K Number
- K052719
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1785
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Arj Medical, Inc.
- Date Received
- September 29, 2005
- Decision Date
- December 5, 2006
- Product Code
- CDM
- 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 |
|---|---|---|---|
| CDM | Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) | FDA class 1 | Clinical Chemistry |
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