Il Test Amylase
by Instrumentation Laboratory CO
510(k) K974125
Il Test Amylase is a Class II device made by Instrumentation Laboratory CO, cleared under FDA 510(k) K974125 on 17 Dec 1997, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK974125 | Date17 Dec 1997 | StatusActive |
Official records
- FDA 510(k) database K974125
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- JFJ
- Device class
- Class II
- Regulation
- 21 CFR Part 862.1070
- Advisory committee
- Clinical Chemistry
- FDA decision
- SESE Substantially Equivalent
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