FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
STRIPMAX 1210 URINE CHEMISTRY ANALYZER, URIMATE REAGENT STRIP FOR URINALYSIS
K Number: K012829
·
Decision Nov 2, 2001
Classifications
1
FEI Numbers
64
Registration Numbers
64
Same Product Code
45
Applicant Total
3
Review Days
71
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Basic Information
- Device Name
- STRIPMAX 1210 URINE CHEMISTRY ANALYZER, URIMATE REAGENT STRIP FOR URINALYSIS
- K Number
- K012829
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2900
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Biocare Corp.
- Date Received
- August 23, 2001
- Decision Date
- November 2, 2001
- 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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