510(k) K924578
K924578 is an FDA 510(k) premarket notification submitted by Ventana Medical Systems, Inc. for the device "PSA ANTIBODY KIT". The FDA issued a decision of Substantially Equivalent on February 5, 1993. The device falls under product code DFD (Kappa, Peroxidase, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5550. Ventana Medical Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 5, 1993
- Date Received
- September 10, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Kappa, Peroxidase, Antigen, Antiserum, Control
- Device Class
- Class II
- Regulation Number
- 866.5550
- Review Panel
- PA
- Submission Type