Il Test Lipase
by Instrumentation Laboratory CO
510(k) K952647
Il Test Lipase is a Class I device made by Instrumentation Laboratory CO, cleared under FDA 510(k) K952647 on 20 Jul 1995, 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 | NumberK952647 | Date20 Jul 1995 | StatusActive |
Official records
- FDA 510(k) database K952647
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- CHI
- Device class
- Class I
- Regulation
- 21 CFR Part 862.1465
- Advisory committee
- Clinical Chemistry
- FDA decision
- SESE Substantially Equivalent
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