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Behring Diagnostics, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
145
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K973832OPUS HLH CONTROLSOctober 27, 1997
K972929N ANTISERUM TO HUMAN ALBUMINOctober 20, 1997
K972840N ANTISERUM TO HUMAN TRANSFERRINOctober 17, 1997
K973202MODIFICATION OF OPUS FERRITIN TEST SYSTEMSeptember 12, 1997
K972316OPUS D-DIMERSeptember 9, 1997
K972116VON WILLEBRAND REAGENTJuly 25, 1997
K972011OPUS ETHANOLJuly 22, 1997
K971600EMIT CALIBRATOR B LEVEL 1 (CUTOFF)/EMIT CALIBRATOR B LEVEL 2 (HIGH)June 25, 1997
K971596EMIT II OPIATES 300/2000 ASSAYJune 25, 1997
K964595OPUS PSA TEST SYSTEMJune 24, 1997
K971725OPUS PROGESTERONEJune 18, 1997
K970645BC THROMBIN REAGENTMay 19, 1997
K970431BEHRING COAGULATION SYSTEMMay 5, 1997
K964764OPUS BONE ALPJanuary 24, 1997
K964527N RHEUMATOLOGY STANDARD SLJanuary 15, 1997
K964687N LATEX CRP MONO REAGENTDecember 16, 1996
K962968PROC APC ASSAY, PROC CONTROL PLASMADecember 13, 1996
K964062N PROTEIN STRANDARD SLNovember 21, 1996
K964065N/T PROTEIN CONTROL SLNovember 6, 1996
K963084OPUS CMV TEST SYSTEM-MODIFICATIONOctober 9, 1996