Bactidrop Ninhydrin
by Remel, Inc.
510(k) K920971
Bactidrop Ninhydrin is a Class I device made by Remel, Inc., cleared under FDA 510(k) K920971 on 22 May 1992, 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 | NumberK920971 | Date22 May 1992 | StatusActive |
Official records
- FDA 510(k) database K920971
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- Withdrawn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