FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM, STRIPS AND CALCHEK KIT
K Number: K101852
·
Decision Mar 23, 2011
Classifications
1
FEI Numbers
68
Registration Numbers
68
Same Product Code
45
Applicant Total
1
Review Days
265
Basic Information
- Device Name
- CHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM, STRIPS AND CALCHEK KIT
- K Number
- K101852
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2900
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- IRIS INTERNATIONAL INC., A DIVISION OF IRIS IRIS I
- Date Received
- July 1, 2010
- Decision Date
- March 23, 2011
- 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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