Sporicidin Brand Disinfectant Solution
FDA 510(k) K904581 · Sporicidin Intl.
510(k) numberK904581
Submission
- Device name
- Sporicidin Brand Disinfectant Solution
- Applicant
- Sporicidin Intl.
Rockville, MD, US - Received
- October 9, 1990
- Decision date
- May 18, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K003087 | Modification to Sporicidin Sterilizing and Disinfecting SolutionMED · Traditional | 11/07/2000SE |
| K983194 | Sporicidin Sterilizing and Disinfecting Solution (SSDS)MED · Traditional | 03/05/1999SE |
| K926013 | Sporicidin Brand Disinfect Towel, Spray/Solut ModiLRJ · Traditional | 02/12/1993SE |
| K922262 | Sporicidin Brand Disinfect Towelettes/Spray/SolutLRJ · Traditional | 09/15/1992SN |
| K904580 | Sporicidin Brand Disinfectant SprayLRJ · Traditional | 05/18/1992SE |
| K904579 | Sporicidin Brand Disinfectant TowelettesLRJ · Traditional | 05/18/1992SE |
| K830722 | Sporididin-D Cold Sterilizing/SolutionLIF · Traditional | 06/30/1983SE |
Questions and answers
When was Sporicidin Brand Disinfectant Solution cleared by the FDA?
Sporicidin Brand Disinfectant Solution (K904581) received a 510(k) decision of Substantially Equivalent on May 18, 1992, 587 days after the submission was received.
What is the product code of K904581?
The FDA product code is LRJ – Disinfectant, Medical Devices, a Class I (low risk) device regulated under 21 CFR 880.6890.