FDA 510(k)
FDA class 1
Substantially Equivalent
🇨🇦 Canada
ELITECH GAMMA GT TEST KIT
K Number: K901090
·
Decision Mar 29, 1990
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
32
Applicant Total
5
Review Days
22
Basic Information
- Device Name
- ELITECH GAMMA GT TEST KIT
- K Number
- K901090
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1360
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Elite Technology, Inc.
- Date Received
- March 7, 1990
- Decision Date
- March 29, 1990
- Product Code
- JPZ
- 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 |
|---|---|---|---|
| JPZ | Colorimetric Method, Gamma-Glutamyl Transpeptidase | FDA class 1 | Clinical Chemistry |
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