Medical Laboratory Automation Systems, Inc.

FDA Regulatory Profile

Summary

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

Recent 510(k) Clearances

K-NumberDeviceDate
K962664ELECTRA 1800C AUTOMATIC COAGULATION ANALYZERSeptember 10, 1996
K944227ELECTRA 1400C AUTOMATIC COAGULATION ANALYZERFebruary 3, 1995
K931206ELECTRA 1600C AUTOMATIC COAGULATION TIMERAugust 23, 1993
K923220THROMBIN CLOT TIME TEST PROCEDURESeptember 29, 1992
K903638GASTRO-INTESTINAL ACCU-CULSHURE TMJanuary 18, 1991
K903405CHLAMYDIA ACCU-CULSHURE TMOctober 16, 1990
K903406VIRAL ACCU-CULSHURE TMOctober 16, 1990
K901645ANAEROBIC ACCU-CULSHURE(TM)July 16, 1990
K894052ELECTRA 1000C AUTOMATIC COAGULATION TIMERJuly 27, 1989
K884863ELECTRA 900C AUTOMATIC COAGULATION TIMERFebruary 3, 1989
K871687TYTEM(R) REAGENT DISPENSERMay 20, 1987
K864875ELECTRA AUTOMATIC SAMPLERFebruary 13, 1987
K864532ELECTRA(R) 700 AUTOMATIC COAGULATION TIMERFebruary 6, 1987
K864534ELECTRA(R) 800 AUTOMATIC COAGULATION TIMERFebruary 6, 1987
K851169ELECTRA 800 AUTOMATIC COAGULATION TIMERJune 24, 1985
K812124MLA ELECTRA 700October 2, 1981
K780810MLA ELECTRA 750 COAGULATION TIMERJune 14, 1978