FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
PROTEIN TEST FOR URINE AND CSF
K Number: K900733
·
Decision Jul 10, 1990
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
115
Applicant Total
5
Review Days
144
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Basic Information
- Device Name
- PROTEIN TEST FOR URINE AND CSF
- K Number
- K900733
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1635
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Elite Technology, Inc.
- Date Received
- February 16, 1990
- Decision Date
- July 10, 1990
- Product Code
- CEK
- 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 |
|---|---|---|---|
| CEK | Biuret (Colorimetric), Total Protein | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
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