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FDA 510(k) Applications Submitted by REBECCA A RIVAS
FDA 510(k) Number
Submission Date
Device Name
Applicant
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.
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