Teco Diagnostics - FDA 510(k) Cleared Devices
51
Total
51
Cleared
0
Denied
51 devices
Cleared
Jan 20, 2000
ALKALINE PHOSPHATASE LIQUID REAGENT-KINETIC, MODELS A504-150 AND A504-500H
Chemistry
10d
Cleared
Jun 29, 1998
AST/SGOT LIQUID REAGENT - KINETIC METHOD
Chemistry
49d
Cleared
Apr 16, 1998
UREA NITROGEN (BUN) LIQUID REAGENT
Chemistry
21d
Cleared
Jul 03, 1997
ONE STEP MARIJUANA CARD TEST
Toxicology
141d
Cleared
Jul 03, 1997
ONE STEP MORPHINE CARD TEST
Toxicology
139d
Cleared
Apr 08, 1997
CLINISTRIP
Chemistry
76d
Cleared
Mar 24, 1997
BILE ACIDS REAGENT SET
Chemistry
69d
Cleared
Mar 06, 1997
LIPASE REAGENT SET (COLIPASE METHOD)
Chemistry
51d
Cleared
Feb 11, 1997
ONE -STEP URINE/SERUM COMBO PREGNANCY CARD TEST
Chemistry
96d
Cleared
Feb 11, 1997
ONE-STEP URINE/SERUM COMNO PREGNANCY DIPSTICK TEST
Chemistry
96d
Cleared
Feb 11, 1997
ONE-STEP DIPSTICK PREGNANCY TEST
Chemistry
91d
Cleared
Nov 25, 1996
RHEUMATOID FACTOR (RF) REAGENTI A LATEX SLIDE TEST
Immunology
187d
Cleared
Nov 25, 1996
C-REACTIVE PROTEIN (CRP):A LATEX SLIDE TEST
Immunology
186d
Cleared
Oct 24, 1996
CSF/URINE TOTAL PROTEIN
Chemistry
163d
Cleared
Sep 11, 1996
THYROID STIUMLATING HORMONE (TSH-BEADS ASSAY) TEST
Chemistry
138d
Cleared
Mar 11, 1996
URINE REAGENTS STRIPS-8 PARAMETERS (MODIFICATION)
Chemistry
147d
Cleared
Jan 29, 1996
URINE REAGENT STRIPS-3 PARAMETERS (MODIFICATION)
Chemistry
82d
Cleared
Apr 24, 1995
URINE REAGENT STRIPS-8 PARAMETERS
Chemistry
280d
Cleared
Mar 24, 1995
IN VITRO DIAGNOSTIC URINE REAGENT STRIPS SET
Chemistry
294d
Cleared
Mar 20, 1995
CARBON DIOXIDE (C02)
Chemistry
283d
Cleared
Mar 13, 1995
SERUM @-HYDROXYBUTYRATE DEHYDROGENASE (HBDH)
Chemistry
354d
Cleared
Oct 04, 1994
MULTI ANALYTE LINEARITY SET
Chemistry
278d
Cleared
Sep 09, 1994
URINE REAGENT STRIP-3 PARAMETERS
Chemistry
219d
Cleared
Apr 15, 1994
ONE STEP PREGNANCY TEST
Chemistry
119d
Cleared
Nov 05, 1993
AMYLASE REAGENT SET (KINETIC)
Chemistry
248d