Amerse 2
510(k) K983947
Amerse 2 is a medical device (FDA Class I; FDA product code LRJ, Disinfectant, Medical Devices) made by Steris Corporation, cleared under FDA 510(k) K983947 on 4 Dec 1998, 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 | NumberK983947 | Date4 Dec 1998 | StatusActive |
Official records
- FDA 510(k) database K983947
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- LRJ
- Device class
- Class I
- Regulation
- 21 CFR Part 880.6890
- Advisory committee
- General Hospital
- FDA decision
- SESE Substantially Equivalent
Similar devices
Other devices filed under FDA product code LRJ (Disinfectant, Medical Devices).
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- DISPATCH HOSPITAL CLEANER DISINFECTANT TOWELS WITH BLEACH by Caltech Industries, Inc.
- CIDEX ACTIVATED DIALDEHYDE SOLUTION by Johnson & Johnson Medical, Inc.
- SPORICIDIN BRAND DISINFECT TOWEL, SPRAY/SOLUT MODI by Sporicidin Intl.
- MULTI-WASH by Multi-Wash Medical, Ltd.
- GERMICIDAL CLOTH by Convatec, A Division of E.R. Squibb & Sons
- AMERSE by Calgon Vestal Div.
- COLDCIDE-2 by METREX RESEARCH
- SPORICIDIN BRAND DISINFECTANT TOWELETTES by Sporicidin Intl.
- HEATED INSTRUMENT BATH by Simpson/Basye, Inc.