Submission Details
| 510(k) Number | K983947 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 05, 1998 |
| Decision Date | December 04, 1998 |
| Days to Decision | 29 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Traditional
AMERSE 2
Dec 1998
Decision
29d
Days
Class 1
Risk
About This 510(k) Submission
K983947 is an FDA 510(k) clearance for the AMERSE 2, a Disinfectant, Medical Devices (Class I — General Controls, product code LRJ), submitted by STERIS Corporation (St. Louis, US). The FDA issued a Cleared decision on December 4, 1998, 29 days after receiving the submission on November 5, 1998. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6890.
Device Classification
| Product Code | LRJ — Disinfectant, Medical Devices |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 880.6890 |
Manufacturer
Similar Devices — LRJ Disinfectant, Medical Devices
All 72
K992661 · Maril Products, Inc.
· Sep 1999
K991509 · Sultan Chemists, Inc.
· Jul 1999
K984485 · Chemlink Laboratories, LLC
· Jan 1999
K983869 · Caltech Industries, Inc.
· Nov 1998
K983585 · Central Solutions, Inc.
· Nov 1998
K982985 · Caltech Industries, Inc.
· Nov 1998
More from STERIS Corporation
View all
K252680
· FRC · Sep 2025
K251048
· JOJ · May 2025
K243876
· JOJ · Apr 2025
K250842
· PKL · Apr 2025
K250044
· FRC · Feb 2025