FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OLYMPUS URINE CALIBRATOR
K Number: K033910
·
Decision Jan 30, 2004
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
301
Applicant Total
36
Review Days
44
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Basic Information
- Device Name
- OLYMPUS URINE CALIBRATOR
- K Number
- K033910
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1150
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Cliniqa Corporation
- Date Received
- December 17, 2003
- Decision Date
- January 30, 2004
- Product Code
- JIX
- 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 |
|---|---|---|---|
| JIX | Calibrator, Multi-Analyte Mixture | FDA class 2 | Clinical Chemistry |
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|---|---|---|---|
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| K060322 | CLINIQA DRY QC CHEMISTRY CONTROL, LEVELS 1 AND 2, ASSAYED, CLINIQA DRY QC CHEMISTRY CONTROL, LEVEL 1 AND 2 UNASSAYED | Mar 21, 2006 | Substantially Equivalent |