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Coulter Electronics, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
101
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K923951CD8 CYTOSPHERES KITApril 25, 1994
K930119COULTER RETIC-C CELL CONTROLApril 5, 1993
K921279CD4 CYTOSPHERES KITDecember 29, 1992
K923530COULTER MULTI-Q-PREPOctober 14, 1992
K922181COULTER MH009August 17, 1992
K922704COULTER MAXM W/ AUTOLOADERJuly 27, 1992
K921567COULTER MH017July 6, 1992
K912133PX COULTER(R) CELL CONTROLJuly 17, 1991
K911385COULTER(R) MH010June 17, 1991
K905771COULTER DART AST (GOT) REAGENTFebruary 26, 1991
K905767COULTER DART ALT (GPT) REAGENTJanuary 25, 1991
K905622COULTER DIRECT BILLRUBIN REAGENTDecember 26, 1990
K904866COULTER CK-MB ISOENZYME REAGENTDecember 13, 1990
K897162COULTER CHOLESTEROL REAGENTMarch 29, 1990
K897164COULTER LD (LDH-L) REAGENTMarch 9, 1990
K897159COULTER TRIGLYCERIDES GPO REAGENTMarch 9, 1990
K897163COULTER ALT (GPT) REAGENTMarch 9, 1990
K897160COULTER GLUCOSE REAGENTMarch 9, 1990
K897161COULTER URIC ACID REAGENTMarch 1, 1990
K897165COULTER AST (GOT) REAGENTFebruary 23, 1990