Biokit USA, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
16
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K913467TOXOGENJanuary 11, 1993
K910541BIOKIT RPROctober 18, 1991
K904310RHEUMAGEN RF T-CONTROLMay 31, 1991
K910539RHEUMAJET RFApril 5, 1991
K910686RHEUMAJET CRPMarch 19, 1991
K904311RHEUMAGEN ASO T-CONTROLJanuary 25, 1991
K904312RHEUMAGEN CRP T-CONTROLOctober 1, 1990
K896433MODIFIED RUBAGENNovember 29, 1989
K896271QUANTEX RF PLUS (LATEX, BUFFER STANDARD, CONTROL)November 8, 1989
K896272QUANTEX CRP PLUS (LATEX, BUFFER, STANDARD, CONTROLNovember 8, 1989
K894486QUANTEX ASO PLUS (LATEX,BUFFER STANDARD,CONTROL)October 24, 1989
K893755RUBAGENAugust 21, 1989
K874678I.M.N. LATEXDecember 14, 1987
K854991REUMAGEN ASLApril 18, 1986
K843741RPR TEST REDITESTOctober 25, 1984
K842256AS LATEX PLUSJune 19, 1984