Home / Companies / Smithkline Diagnostics, Inc.

Smithkline Diagnostics, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
42
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K961062FLEXSURE OBTNovember 6, 1996
K960183FLEXSURE HP,CONTROLS FOR FLEXSUREHP,FLEXPACK HP(ABBOTT DIAGNOSTICS)ANDCONTROLS FOR FLEXPACK HP (ABBOJune 7, 1996
K934863FLEXSURE HPMay 18, 1994
K880499HEMOCCULT SENSITIVE TESTMay 23, 1988
K875131(SKD) CHOLESTEROL TEST KITMarch 1, 1988
K862849HEMOCCULT WIPE TESTDecember 9, 1986
K854723SKD ELECTROCHEMICAL SYSTEM (ECS)March 5, 1986
K852841RAPID DIRECT STREP A LATEX AGGLUTINATION TESTJuly 24, 1985
K821884GASTROCCULT TMOctober 8, 1982
K821674SPINCHEM ACID PHOSPHATASE REAGENTJune 22, 1982
K821184SPIN CHEM REAGENTS & STANDARDSMay 24, 1982
K821183TARGET ISOCHECK CONTROL SERUMMay 14, 1982
K812646SKI 5000November 16, 1981
K812472SPIN-CHEM LD-L REAGENTSeptember 14, 1981
K812471SPIN-CHEM TRIGLYCERIDES REAGENTSeptember 14, 1981
K811850ESKAFLOW TEST FOR TRIGLYCERIDESJuly 23, 1981
K811849ESKAFLOW TEST FOR GLUCOSEJuly 15, 1981
K8109145CM SMALL PARTS SCANNERMay 8, 1981
K803234ESKACHEM PAP REAGENTFebruary 26, 1981
K801060HIGH RESOLUTION 10CM DIAG. ULTRA. SCANNEJune 4, 1980