510(k) K792574
K792574 is an FDA 510(k) premarket notification submitted by Electrophoresis Corp. of America for the device "MOPSO BUFFER". The FDA issued a decision of Substantially Equivalent on January 21, 1980. The device falls under product code JCC (Ph Buffer), a Class I device regulated under 21 CFR 864.4010. Electrophoresis Corp. of America has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 21, 1980
- Date Received
- December 13, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ph Buffer
- Device Class
- Class I
- Regulation Number
- 864.4010
- Review Panel
- PA
- Submission Type