FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
URITEST 50 AND URITEST 500 URINE ANALYZER
K Number: K091472
·
Decision Apr 27, 2010
Classifications
1
FEI Numbers
64
Registration Numbers
64
Same Product Code
45
Applicant Total
3
Review Days
344
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Basic Information
- Device Name
- URITEST 50 AND URITEST 500 URINE ANALYZER
- K Number
- K091472
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2900
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Arj Medical, Inc.
- Date Received
- May 18, 2009
- Decision Date
- April 27, 2010
- Product Code
- KQO
- 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 |
|---|---|---|---|
| KQO | Automated Urinalysis System | FDA class 1 | Clinical Chemistry |
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