510(k) K830911
K830911 is an FDA 510(k) premarket notification submitted by Biocell Laboratories, Inc. for the device "RADIAL IMMUNODIFFUSION PLATES". The FDA issued a decision of Substantially Equivalent on Jun 10, 1983. The device falls under product code DDG (Transferrin, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5880. Biocell Laboratories, Inc. has 5 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 10, 1983
- Date Received
- Mar 21, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Transferrin, Antigen, Antiserum, Control
- Device Class
- Class II
- Regulation Number
- 866.5880
- Review Panel
- IM
- Submission Type
- 510(k)