510(k) K970825
K970825 is an FDA 510(k) premarket notification submitted by S.C. Johnson Professional for the device "BLUE CHIP GERMICIDAL CLEANER & DEODORANT". The FDA issued a decision of Substantially Equivalent on March 14, 1997. The device falls under product code LRJ (Disinfectant, Medical Devices), a Class I device regulated under 21 CFR 880.6890.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 14, 1997
- Date Received
- March 6, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Disinfectant, Medical Devices
- Device Class
- Class I
- Regulation Number
- 880.6890
- Review Panel
- HO
- Submission Type