510(k) K792709
K792709 is an FDA 510(k) premarket notification submitted by Meridian Diagnostics, Inc. for the device "KOH MOUNTING FLUID W/GLYCEROL". The FDA issued a decision of Substantially Equivalent on January 24, 1980. The device falls under product code KEQ (Media, Mounting, Water Soluble), a Class I device regulated under 21 CFR 864.4010. Meridian Diagnostics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 24, 1980
- Date Received
- December 27, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Media, Mounting, Water Soluble
- Device Class
- Class I
- Regulation Number
- 864.4010
- Review Panel
- PA
- Submission Type