A.C.T. I
by Remel, Inc.
510(k) K965149
A.C.T. I is a Class I device made by Remel, Inc., cleared under FDA 510(k) K965149 on 22 Jan 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 | NumberK965149 | Date22 Jan 1997 | StatusActive |
Official records
- FDA 510(k) database K965149
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- JSM
- FDA applicant
- Remel Co.
- Device class
- Class I
- Regulation
- 21 CFR Part 866.2390
- Advisory committee
- Microbiology
- FDA decision
- SESE Substantially Equivalent