510(k) K113015
K113015 is an FDA 510(k) premarket notification submitted by Microchem Laboratories, Inc. for the device "ALDAHOL V HIGH LEVEL DISINFECTANT". The FDA issued a decision of Substantially Equivalent on January 30, 2012. The device falls under product code MED (Sterilant, Medical Devices), a Class II device regulated under 21 CFR 880.6885.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 30, 2012
- Date Received
- October 11, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Sterilant, Medical Devices
- Device Class
- Class II
- Regulation Number
- 880.6885
- Review Panel
- HO
- Submission Type