FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
GONOTEC CALIBRATION SOLUTION 300 MOSMOL/KG FOR OSMOMETER
K Number: K032608
·
Decision Oct 21, 2003
Classifications
1
FEI Numbers
72
Registration Numbers
72
Same Product Code
129
Applicant Total
1
Review Days
57
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Basic Information
- Device Name
- GONOTEC CALIBRATION SOLUTION 300 MOSMOL/KG FOR OSMOMETER
- K Number
- K032608
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 862.1150
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Gonotec Gesellschaft Fuer Mess-Und Regeltechnik MB
- Date Received
- August 25, 2003
- Decision Date
- October 21, 2003
- Product Code
- JIS
- 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 |
|---|---|---|---|
| JIS | Calibrator, Primary | FDA class 2 | Clinical Chemistry |
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