510(k) K882344
K882344 is an FDA 510(k) premarket notification submitted by The W.E.P. Co. for the device "ELECTR-TRANSBLOTTER". The FDA issued a decision of Substantially Equivalent on January 13, 1989. The device falls under product code JJN (Apparatus, Electrophoresis, For Clinical Use), a Class I device regulated under 21 CFR 862.2485.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 13, 1989
- Date Received
- June 7, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Apparatus, Electrophoresis, For Clinical Use
- Device Class
- Class I
- Regulation Number
- 862.2485
- Review Panel
- CH
- Submission Type