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Seratronics, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
21
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K955299DPS 4 DIALYZER PREPARATION SYSTEMOctober 21, 1996
K931336DRS 4 DIALYZER REPROCESSING SYSTEMApril 18, 1996
K944539DRS 4 ND DIALYZER REPROCESSING SYSTEMNovember 29, 1995
K923529DMS DATA MANAGEMENT SYSTEM/DRS-4 DIALYZER REPROCESAugust 29, 1994
K914580DRS-4 DIALYZER REPROCESSING SYSTEMFebruary 24, 1992
K874573FRESENIUS PURISTERIL 340 (TM)April 25, 1988
K874872FRESENIUS HEMOFLOW F3, F4, F5, F7February 19, 1988
K870725FRESENIUS HEMOFLOW F6 AND F8May 1, 1987
K870724FRESENIUS HEMOFLOW F60 AND F80April 1, 1987
K864587FRESENIUS ULTRAFLUX AV400, AV600March 3, 1987
K864169FRESENIUS HEMOFLOW F50 & F70November 6, 1986
K860674DRS-4 DIALYZER REPROCESSING SYSTEMApril 7, 1986
K861106FRESENIUS HEMOFLOW F80 DIALYZERApril 7, 1986
K855001FRESENIUS HEMODIALYSIS MACHINE A1008 BSMJanuary 21, 1986
K853851FRESENIUS DISPOSABLE BLOOD LINESNovember 12, 1985
K852251FRESENIUS HEMOFLOW F60 & FRESENIUS HEMOFLOW F40July 25, 1985
K844750FRESENIUS A2008 HEMODIALYSIS MACHINE EXPANSION MODFebruary 15, 1985
K844641FRESENIUS HAEMODIALYSIS ;MACHINE A1008February 14, 1985
K843014FRESENIUS HAEMODIALYSIS A2008October 18, 1984
K832230DIALYZER PREPARATION SYS DPS-4October 14, 1983