510(k) K831811

REVOLUTION RADIAL IMMUNODIFFUSION PLATE by Calbiochem-Behring Corp. — Product Code JZQ

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