FDA 510(k) Applications Submitted by ORGANON TEKNIKA CORP.

FDA 510(k) Number Submission Date Device Name Applicant
K962857 07/22/1996 COAG-A-MATE MTX ORGANON TEKNIKA CORP.
K954468 09/26/1995 MB/BACT MYCROBACTERIA DETECTION SYSTEM ORGANON TEKNIKA CORP.
K000378 02/07/2000 BACT/ALERT MB CULTURE BOTTLE ORGANON TEKNIKA CORP.
K991101 04/01/1999 COAG-A-MATE MAX ORGANON TEKNIKA CORP.
K981736 05/18/1998 BACT/ALERT 3D MICROBIAL DETECTION SYSTEM ORGANON TEKNIKA CORP.
K982263 06/29/1998 MB/BACT BLOOD CULTURE BOTTLE ORGANON TEKNIKA CORP.
K972698 07/18/1997 TOF-WATCH ORGANON TEKNIKA CORP.
K992400 07/19/1999 BACTALERT FA ORGANON TEKNIKA CORP.
K992401 07/19/1999 BACT/ALERT PF ORGANON TEKNIKA CORP.
K992432 07/21/1999 BACT/ALERT FN ORGANON TEKNIKA CORP.
K992596 08/03/1999 TOF-WATCH S ORGANON TEKNIKA CORP.
K992598 08/03/1999 TOF-WATCH SX ORGANON TEKNIKA CORP.
K003104 08/29/2000 BACT/ALERT CSR ORGANON TEKNIKA CORP.
K973305 09/03/1997 BACT/ALERT CULTURE BOTTLES ORGANON TEKNIKA CORP.
K973325 09/04/1997 BACT/ALERT FAN CULTURE BOTTLES ORGANON TEKNIKA CORP.
K993421 10/12/1999 BACT/ALERT SN ORGANON TEKNIKA CORP.
K993423 10/12/1999 BACT/ALERT SA ORGANON TEKNIKA CORP.
K993576 10/21/1999 BACT/ALERT MP PROCESS BOTTLE ORGANON TEKNIKA CORP.
K983772 10/26/1998 MB/BACT BLOOD CULTURE BOTTLE ORGANON TEKNIKA CORP.
K974566 12/05/1997 MDA SIMPLASTIN HTF ORGANON TEKNIKA CORP.
K994343 12/23/1999 BACT/ALERT SV ORGANON TEKNIKA CORP.
K000492 02/15/2000 MDA D-DIMER ORGANON TEKNIKA CORP.
K983762 10/26/1998 NUCLISENS CMV PP67 ORGANON TEKNIKA CORP.
K964934 12/09/1996 THROMBONOSTIKA F1.2 ORGANON TEKNIKA CORP.
K965076 12/19/1996 MDA HEPARIN ANTI-X ASSAY ORGANON TEKNIKA CORP.
K974776 12/22/1997 MDA D-DIMER ORGANON TEKNIKA CORP.


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