510(k) K811740
K811740 is an FDA 510(k) premarket notification submitted by Kallestad Laboratories, Inc. for the device "KALLESTAD'S ENDOPLATE FACTOR B TEST". The FDA issued a decision of Substantially Equivalent on July 16, 1981. The device falls under product code JZH (Factor B, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5320. Kallestad Laboratories, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 16, 1981
- Date Received
- June 19, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Factor B, Antigen, Antiserum, Control
- Device Class
- Class II
- Regulation Number
- 866.5320
- Review Panel
- IM
- Submission Type