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Labsystems, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
17
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K923365TILT/REDUCED SHEAR SEMI-RECLINE SEATING SYSTEMMarch 24, 1993
K896474RESUBMITTED FECATWIN SENSITIVE - FECA-EIAJanuary 25, 1990
K890154MODIFIED LABYSYSTEMS' TOXOPLASMA GONDII IGG EIAFebruary 7, 1989
K890091MODIFIED LABSYSTEMS' RUBELLA IGG EIA TEST KITFebruary 3, 1989
K881243RUBELLA IGG - EIA TEST KIT NUMBER 61 07 201April 4, 1988
K873780MODIFICATION RUBELLA IGM EIA TEST KITOctober 15, 1987
K873583AUTO-EIASeptember 22, 1987
K872252MODIFIED TOXOPLASMA GONDII IGG EIA TEST KITJuly 1, 1987
K862705CYTOMEGALOVIRUS IGG EIA TEST KITOctober 1, 1986
K862431RUBELLA IGM EIA TEST KITAugust 8, 1986
K862216TOXOPLASMA GONDII IGG EIA TEST KIT (AMENDMENT)June 30, 1986
K853696RUBELLA IGG EIA TEST KITJune 17, 1986
K843189CYTOMEGALOVIRUS IGG EIA TEST KITJanuary 8, 1986
K842797TOXOPLASMA GONDII IGM EIA TEST KITOctober 17, 1984
K842773LABSYSTEMS FP-901 CHEMISTRY ANALYZERSeptember 4, 1984
K833829TOXOPLASMA GOND II IGG DIA TEST KITApril 24, 1984
K841214LABSYSTEMS UNISKANApril 13, 1984