Bacticard E. Coli
by Remel, Inc.
510(k) K934986
Bacticard E. Coli is a Class I device made by Remel, Inc., cleared under FDA 510(k) K934986 on 23 Feb 1994, 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 | NumberK934986 | Date23 Feb 1994 | StatusActive |
Official records
- FDA 510(k) database K934986
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- JTO
- FDA applicant
- Remel Co.
- Device class
- Class I
- Regulation
- 21 CFR Part 866.2660
- Advisory committee
- Microbiology
- FDA decision
- SESE Substantially Equivalent