FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AMYLASE
K Number: K980013
·
Decision Feb 4, 1998
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
30
Applicant Total
3
Review Days
33
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Basic Information
- Device Name
- AMYLASE
- K Number
- K980013
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1070
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Ac Biochemicals, Inc.
- Date Received
- January 2, 1998
- Decision Date
- February 4, 1998
- Product Code
- CIJ
- 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 |
|---|---|---|---|
| CIJ | Saccharogenic, Amylase | FDA class 2 | Clinical Chemistry |
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