Medical Device Manufacturer · US , Mchenry , IL

Organon Teknika Corp.

130 submissions · 129 cleared · Since 1980
130
Total
129
Cleared
0
Denied

Organon Teknika Corp. — FDA 510(k) Submissions

Organon Teknika Corp. has submitted 130 FDA 510(k) premarket notifications since 1980, of which 129 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include System, Blood Culturing, System, Dialysate Delivery, Sorbent Regenerated, Susceptibility Test Discs, Antimicrobial, Dialyzer, Capillary, Hollow Fiber, Test, Time, Prothrombin . Use the specialty filter in the sidebar to narrow results.

130 devices
1–12 of 130
BACT/ALERT CSR
K003104 · LJF Device, Antimicrobial... · Microbiology
Oct 2000 52d
MDA D-DIMER
K000492 · DAP Fibrinogen And Fibrin... · Hematology
Jun 2000 113d
BACT/ALERT MB CULTURE BOTTLE
K000378 · MDB System, Blood Culturing · Microbiology
Mar 2000 24d
BACT/ALERT SV
K994343 · MDB System, Blood Culturing · Microbiology
Feb 2000 49d
BACT/ALERT SA
K993423 · MDB System, Blood Culturing · Microbiology
Dec 1999 64d
BACT/ALERT SN
K993421 · MDB System, Blood Culturing · Microbiology
Dec 1999 63d
BACT/ALERT MP PROCESS BOTTLE
K993576 · MDB System, Blood Culturing · Microbiology
Dec 1999 54d
BACT/ALERT FN
K992432 · MDB System, Blood Culturing · Microbiology
Sep 1999 65d
NUCLISENS CMV PP67
K983762 · LIN Antisera, Conjugated... · Microbiology
Sep 1999 324d
BACTALERT FA
K992400 · MDB System, Blood Culturing · Microbiology
Sep 1999 46d
BACT/ALERT PF
K992401 · MDB System, Blood Culturing · Microbiology
Sep 1999 46d
TOF-WATCH S
K992596 · KOI Stimulator, Nerve,... · Anesthesiology
Aug 1999 27d

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