Bioclinical Systems, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
13
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K950196CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIAJune 30, 1995
K945911CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, MUELLER HINTON AGARSApril 4, 1995
K933122MICROBIOLOGICAL CULTURE MEDIA,MARTIN LEWIS AGARFebruary 9, 1994
K933121MICROBIOLOGICAL CULTURE MEDIA,CHOCOLATE AGARFebruary 3, 1994
K873086ROUND 1August 24, 1987
K860334VISI-CHECK HLH TEST MONOCLONALApril 21, 1986
K860333MICRO-ELISA HLH TEST KIT MONOCLONALApril 21, 1986
K855227MICRO-EIA THEOPHYLLINE TEST KIT MONOCLONALApril 11, 1986
K854059MICRO-ELISA HCG EST KIT VISI-CHECK HCG TEST KIT NOJanuary 13, 1986
K854379MICRO-ELISA TSH TEST KIT-VISI-CHECK TSH TEST KITJanuary 7, 1986
K850257BCS GLUCOSE COLORIMETRIC TESTMarch 5, 1985
K850079NOW HOME PREGN. TEST KIT ENZYME IMMUNOASSAY HCGMarch 5, 1985
K850258BCS POTASSIUM TURBIDIMETRIC TESTFebruary 7, 1985