510(k) K940243
K940243 is an FDA 510(k) premarket notification submitted by Ventana Medical Systems, Inc. for the device "VENTANA EMA PRIMARY ANDIBODY". The FDA issued a decision of Substantially Equivalent on September 7, 1994. The device falls under product code DHF (D/Km-1, Antigen, Antiserum, Control), a Class I device regulated under 21 CFR 866.5065. Ventana Medical Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 7, 1994
- Date Received
- January 19, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- D/Km-1, Antigen, Antiserum, Control
- Device Class
- Class I
- Regulation Number
- 866.5065
- Review Panel
- PA
- Submission Type