Amerse
FDA 510(k) K931477 · Calgon Vestal Div.
510(k) numberK931477
Submission
- Device name
- Amerse
- Applicant
- Calgon Vestal Div.
St. Louis, MO, US - Received
- March 24, 1993
- Decision date
- June 17, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LRJ – Disinfectant, Medical Devices
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.6890
- Specialty
- General Hospital
Other 510(k)s with product code LRJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K992661 | Control III EliteLRJ · Traditional | Maril Products, Inc. | 09/14/1999SE |
| K991509 | Pro-Portion Cleaner/DisinfectantLRJ · Traditional | Sultan Chemists, Inc. | 07/14/1999SE |
| K984485 | Microstat 2LRJ · Traditional | Chemlink Laboratories, LLC | 01/13/1999SE |
| K983947 | Amerse 2LRJ · Traditional | STERIS Corporation | 12/04/1998SE |
| K983869 | Dispatch Hospital Cleaner Disinfectant Towels with BleachLRJ · Traditional | Caltech Industries, Inc. | 11/30/1998SE |
| K983585 | Low PH Phenolic 256LRJ · Traditional | Central Solutions, Inc. | 11/06/1998SE |
| K982985 | Citrex Hospital Spray DisinfectantLRJ · Traditional | Caltech Industries, Inc. | 11/02/1998SE |
| K981023 | KleenasepticLRJ · Traditional | Metrex Research Corp. | 04/30/1998SE |
| K980369 | T.B.Q. RtuLRJ · Traditional | STERIS Corporation | 02/17/1998SE |
| K974304 | Germicidal ClothLRJ · Traditional | Convatec, A Division of E.R. Squibb & Sons | 01/13/1998SE |
More from Convatec, A Division of E.R. Squibb & Sons
| 510(k) | Device | Decision |
|---|---|---|
| K944494 | Alsa-KlenzFLG · Traditional | 10/19/1994SE |
| K944033 | Bill Evans-KlenzFLG · Traditional | 10/07/1994SE |
| K942270 | Saf-Gel Hydrating Dermal Wound DressingKMF · Traditional | 08/04/1994SE |
| K931816 | Vesta-Syde(R) Interim Instr Decontamination SystemLRJ · Traditional | 05/26/1994SE |
| K931342 | LPHLRJ · Traditional | 05/26/1994SE |
| K941163 | Mon-KlenzFLG · Traditional | 05/18/1994SE |
| K931573 | Vesphene IILRJ · Traditional | 05/16/1994SE |
| K932277 | Lonza Formulation R-82LRJ · Traditional | 05/12/1994SE |
| K931599 | Hydrasorb Sterile DressingMGP · Traditional | 07/08/1993SE |
| K926034 | Epi-Lock Wound DressingMGP · Traditional | 04/20/1993SE |
Questions and answers
When was Amerse cleared by the FDA?
Amerse (K931477) received a 510(k) decision of Substantially Equivalent on June 17, 1994, 450 days after the submission was received.
What is the product code of K931477?
The FDA product code is LRJ – Disinfectant, Medical Devices, a Class I (low risk) device regulated under 21 CFR 880.6890.