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Boehringer Mannheim Corp.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
340
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K984326ELECYS IGE ASSAYFebruary 8, 1999
K983047ACCU-CHEK HQ SYSTEMFebruary 5, 1999
K984419ELECSYS IGE CALCHECKFebruary 2, 1999
K984425MODIFICATION OF PRECISET SERUM PROTEINS CALIBRATORJanuary 20, 1999
K984372ELECSYS CALCHECK TROPONIN TDecember 14, 1998
K984105ELECSYS TROPONIN T STAT TESTDecember 8, 1998
K983503ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION INORGANIC PHOSPHORUS REAGENT CATALOG NUMBER 17303December 1, 1998
K983469PRECISET SERUM PROTEINS CALIBRATORNovember 25, 1998
K983185BOEHRINGER MANNHEIM TINA-QUANT IGE TESTNovember 12, 1998
K983510CHEMSTRIP 101 URINE ANALYZEROctober 27, 1998
K982948ELECSYS PSA, MODEL # ELECSYS 1010October 27, 1998
K982949ELECSYS PSA, MODEL 2010October 27, 1998
K983416ROCHE DIAGNOSTICS MAGNESIUM REAGENT, CAT# 1551353October 21, 1998
K980724TINAQUANT B 2-MICROGLOBULIN ASSAYOctober 16, 1998
K983492BOEHRINGER MANNHEIM ELECSYS PRESICONTROL CARDIACOctober 9, 1998
K983176ELECSYS MYOGLOBIN STAT ASSAYSeptember 24, 1998
K983166ELECSYS CALCHECK MYOGLOBINSeptember 22, 1998
K982089ACCU-CHEK ADVANTAGE TEST STRIPS AND ACCU-CHEK ADVANTAGE H TEST STRIPSSeptember 3, 1998
K982002ACCU-CHEK COMFORT CURVE TEST STRIPSeptember 2, 1998
K982079ACCU-CHECK VOICEMATEAugust 28, 1998