Il Test Gentamicin Calibrators
by Instrumentation Laboratory CO
510(k) K943982
Il Test Gentamicin Calibrators is a Class II device made by Instrumentation Laboratory CO, cleared under FDA 510(k) K943982 on 25 Jan 1995, active as of 11 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 | NumberK943982 | Date25 Jan 1995 | StatusActive |
Official records
- FDA 510(k) database K943982
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- LCD
- Device class
- Class II
- Regulation
- 21 CFR Part 862.3450
- Advisory committee
- Clinical Toxicology
- FDA decision
- SESE Substantially Equivalent
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