Bionetic Laboratory Products

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
8
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K833637VZV BIO-ENZABEAD SCREEN KITFebruary 10, 1984
K832900IMMUNOENZYME TEST SYS-DETECT-IGM ANTINovember 14, 1983
K832069TOXO IPA KIT IAN INDIRECT FLUORESCENTSeptember 26, 1983
K831760LEGIONELLA IFA KIT IAugust 8, 1983
K830820LEGIONELLA DFA KIT IJune 8, 1983
K831133AMEBIASIS BIO-ENZABEAD SCREEN KITJune 8, 1983
K830405LBI-100 37DEGREES INCUBATORMarch 10, 1983
K830227AUTOMATED ELISA READER LBI 300March 10, 1983