FDA 510(k) Applications Submitted by BEHRING DIAGNOSTICS, INC.

FDA 510(k) Number Submission Date Device Name Applicant
K971600 05/01/1997 EMIT CALIBRATOR B LEVEL 1 (CUTOFF)/EMIT CALIBRATOR B LEVEL 2 (HIGH) BEHRING DIAGNOSTICS, INC.
K971596 05/01/1997 EMIT II OPIATES 300/2000 ASSAY BEHRING DIAGNOSTICS, INC.
K960257 01/18/1996 N ANTISERUM TO C1 INHIBITOR BEHRING DIAGNOSTICS, INC.
K962523 05/30/1996 N LATEX CRP MONO REAGENT BEHRING DIAGNOSTICS, INC.
K962373 06/20/1996 N/T RHEUMATOLOGY CONTROL SL/1 AND SL/2 BEHRING DIAGNOSTICS, INC.
K962406 06/21/1996 N CRP STANDARD SY BEHRING DIAGNOSTICS, INC.
K962407 06/21/1996 N/T PROTEIN CONTROL PY BEHRING DIAGNOSTICS, INC.
K962410 06/21/1996 N PROTEIN STANDARD PY BEHRING DIAGNOSTICS, INC.
K955278 11/17/1995 BEHRING COAGULATION TIMER BEHRING DIAGNOSTICS, INC.
K964595 11/18/1996 OPUS PSA TEST SYSTEM BEHRING DIAGNOSTICS, INC.
K955596 12/08/1995 N LATEX B2-MICROGLOBULIN REAGENT BEHRING DIAGNOSTICS, INC.
K955857 12/27/1995 N PROTEIN STANDARS SY BEHRING DIAGNOSTICS, INC.
K955858 12/27/1995 N/T PROTEIN CONTROL SY/L, M AND H BEHRING DIAGNOSTICS, INC.
K964687 09/17/1996 N LATEX CRP MONO REAGENT BEHRING DIAGNOSTICS, INC.
K964065 10/10/1996 N/T PROTEIN CONTROL SL BEHRING DIAGNOSTICS, INC.
K964062 10/10/1996 N PROTEIN STRANDARD SL BEHRING DIAGNOSTICS, INC.
K963084 08/08/1996 OPUS CMV TEST SYSTEM-MODIFICATION BEHRING DIAGNOSTICS, INC.
K960275 01/19/1996 OPUS CK-MB & TOTAL CK CONTROLS BEHRING DIAGNOSTICS, INC.
K961206 03/27/1996 OPUS T3 CONTROLS BEHRING DIAGNOSTICS, INC.
K955450 11/29/1995 PATHROMTIN SL BEHRING DIAGNOSTICS, INC.
K955468 11/30/1995 OPUS PROLACTIN CONTROLS BEHRING DIAGNOSTICS, INC.
K972116 06/05/1997 VON WILLEBRAND REAGENT BEHRING DIAGNOSTICS, INC.
K962519 06/27/1996 EMIT 2000 GENTAMICIN ASSAY AND CALIBRATORS BEHRING DIAGNOSTICS, INC.
K962968 07/30/1996 PROC APC ASSAY, PROC CONTROL PLASMA BEHRING DIAGNOSTICS, INC.
K970431 02/04/1997 BEHRING COAGULATION SYSTEM BEHRING DIAGNOSTICS, INC.
K970645 02/20/1997 BC THROMBIN REAGENT BEHRING DIAGNOSTICS, INC.
K955448 11/29/1995 EMIT II LSD ASSAY, EMIT LSD CALIBRATORS & EMIT LSD CONTROLS BEHRING DIAGNOSTICS, INC.
K955284 11/16/1995 OPUS TROPONIN I BEHRING DIAGNOSTICS, INC.
K971725 05/09/1997 OPUS PROGESTERONE BEHRING DIAGNOSTICS, INC.
K972011 05/30/1997 OPUS ETHANOL BEHRING DIAGNOSTICS, INC.
K972316 06/20/1997 OPUS D-DIMER BEHRING DIAGNOSTICS, INC.
K973202 07/08/1997 MODIFICATION OF OPUS FERRITIN TEST SYSTEM BEHRING DIAGNOSTICS, INC.
K962866 07/23/1996 OPUS HLH BEHRING DIAGNOSTICS, INC.
K972840 08/01/1997 N ANTISERUM TO HUMAN TRANSFERRIN BEHRING DIAGNOSTICS, INC.
K972929 08/08/1997 N ANTISERUM TO HUMAN ALBUMIN BEHRING DIAGNOSTICS, INC.
K973832 10/07/1997 OPUS HLH CONTROLS BEHRING DIAGNOSTICS, INC.
K964527 11/12/1996 N RHEUMATOLOGY STANDARD SL BEHRING DIAGNOSTICS, INC.
K964764 11/27/1996 OPUS BONE ALP BEHRING DIAGNOSTICS, INC.
K962694 07/11/1996 OPUS B12 CONTROLS BEHRING DIAGNOSTICS, INC.
K962841 07/22/1996 OPUS MYOGLOBIN CONTROLS BEHRING DIAGNOSTICS, INC.


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