Lysol I.C. Brand Phenolic Disinfectant Cleaner (Epa Reg. No. 675-46)
FDA 510(k) K963353 · Reckitt Benckiser, Inc.
510(k) numberK963353
Submission
- Device name
- Lysol I.C. Brand Phenolic Disinfectant Cleaner (Epa Reg. No. 675-46)
- Applicant
- Reckitt Benckiser, Inc.
Montvale, NJ, US - Received
- August 26, 1996
- Decision date
- October 18, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
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| K990703 | Sporox II Sterilizing & Disinfecting SolutionMED · Special | 03/30/1999SE |
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Questions and answers
When was Lysol I.C. Brand Phenolic Disinfectant Cleaner (Epa Reg. No. 675-46) cleared by the FDA?
Lysol I.C. Brand Phenolic Disinfectant Cleaner (Epa Reg. No. 675-46) (K963353) received a 510(k) decision of Substantially Equivalent on October 18, 1996, 53 days after the submission was received.
What is the product code of K963353?
The FDA product code is LRJ – Disinfectant, Medical Devices, a Class I (low risk) device regulated under 21 CFR 880.6890.