FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
AMYLASE-SL ASSAY CATALOGUE NUMBER 341-10
K Number: K974053
·
Decision Dec 8, 1997
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
98
Applicant Total
66
Review Days
42
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Basic Information
- Device Name
- AMYLASE-SL ASSAY CATALOGUE NUMBER 341-10
- K Number
- K974053
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1070
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Diagnostic Chemicals , Ltd.
- Date Received
- October 27, 1997
- Decision Date
- December 8, 1997
- Product Code
- JFJ
- 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 |
|---|---|---|---|
| JFJ | Catalytic Methods, Amylase | FDA class 2 | Clinical Chemistry |
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