Organon Teknika Corp. - FDA 510(k) Cleared Devices
130
Total
129
Cleared
0
Denied
21 devices
Cleared
Nov 14, 1995
AURAFLEX TESTOSTERONE CALIBRATOR PACK
Chemistry
218d
Cleared
May 08, 1995
AURAFLEX PROGESTERONE 150TEST PACK
Chemistry
31d
Cleared
May 02, 1995
AURAFLEX CK-MB 200TEST PACK, CALIBRATOR PACK
Chemistry
22d
Cleared
Apr 03, 1995
AURAFLEX(R) ESTRADIOL
Chemistry
104d
Cleared
Mar 21, 1995
AURAFLEX PROLACTIN 200 TEST PACK, CALIBRATOR PACK, DILVENT 1
Chemistry
179d
Cleared
Mar 20, 1995
AURAFLEX HCG
Chemistry
139d
Cleared
Mar 03, 1995
MICROPLATE PROCESSOR 3000
Chemistry
134d
Cleared
Feb 22, 1995
AURA FLEX FT4 200 TEST PACK, FT4 CALIBRATOR PACK
Chemistry
152d
Cleared
Dec 09, 1994
IMX T3 ASSAY
Chemistry
71d
Cleared
Aug 26, 1994
AURAFLEX SYSTEMS
Chemistry
95d
Cleared
Jun 02, 1994
PREDICTOR HOME PREGNANCY TEST
Chemistry
108d
Cleared
May 27, 1988
PREGNOSPIA II
Chemistry
52d