FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
AUTION JET AJ-4270 URINE ANALYZER
K Number: K030600
·
Decision Jul 11, 2003
Classifications
1
FEI Numbers
64
Registration Numbers
64
Same Product Code
45
Applicant Total
3
Review Days
136
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Basic Information
- Device Name
- AUTION JET AJ-4270 URINE ANALYZER
- K Number
- K030600
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2900
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- International Remote Imaging Systems
- Date Received
- February 25, 2003
- Decision Date
- July 11, 2003
- 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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