510(k) K931052
K931052 is an FDA 510(k) premarket notification submitted by Metrex Research Corp. for the device "METRICIDE 28". The FDA issued a decision of Substantially Equivalent on December 6, 1994. The device falls under product code MED (Sterilant, Medical Devices), a Class II device regulated under 21 CFR 880.6885. Metrex Research Corp. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 6, 1994
- Date Received
- February 16, 1993
- 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