510(k) K831811
K831811 is an FDA 510(k) premarket notification submitted by Calbiochem-Behring Corp. for the device "REVOLUTION RADIAL IMMUNODIFFUSION PLATE". The FDA issued a decision of Substantially Equivalent on July 28, 1983. The device falls under product code JZQ (Plates And Equipment, Radial Immunodiffusion), a Class I device regulated under 21 CFR 866.4800. Calbiochem-Behring Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 28, 1983
- Date Received
- June 6, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Plates And Equipment, Radial Immunodiffusion
- Device Class
- Class I
- Regulation Number
- 866.4800
- Review Panel
- IM
- Submission Type