Teco Diagnostics - FDA 510(k) Cleared Devices

Cleared Apr 08, 1997

CLINISTRIP

K970250 · JIL

Chemistry · 76d

Cleared Mar 24, 1997

BILE ACIDS REAGENT SET

K970120 · KWW

Chemistry · 69d

Cleared Mar 06, 1997

LIPASE REAGENT SET (COLIPASE METHOD)

K970124 · CET

Chemistry · 51d

Cleared Feb 11, 1997

ONE -STEP URINE/SERUM COMBO PREGNANCY CARD TEST

K964461 · JHI

Chemistry · 96d

Cleared Feb 11, 1997

ONE-STEP URINE/SERUM COMNO PREGNANCY DIPSTICK TEST

K964462 · JHI

Chemistry · 96d

Cleared Feb 11, 1997

ONE-STEP DIPSTICK PREGNANCY TEST

K964536 · JHI

Chemistry · 91d

Cleared Oct 24, 1996

CSF/URINE TOTAL PROTEIN

K961864 · CEK

Chemistry · 163d

Cleared Sep 11, 1996

THYROID STIUMLATING HORMONE (TSH-BEADS ASSAY) TEST

K961629 · JLW

Chemistry · 138d

Cleared Mar 11, 1996

URINE REAGENTS STRIPS-8 PARAMETERS (MODIFICATION)

K954977 · JRE

Chemistry · 147d

Cleared Jan 29, 1996

URINE REAGENT STRIPS-3 PARAMETERS (MODIFICATION)

K955438 · JIR

Chemistry · 82d

Cleared Apr 24, 1995

URINE REAGENT STRIPS-8 PARAMETERS

K943436 · JJB

Chemistry · 280d

Cleared Mar 24, 1995

IN VITRO DIAGNOSTIC URINE REAGENT STRIPS SET

K942648 · JIL

Chemistry · 294d

Cleared Mar 20, 1995

CARBON DIOXIDE (C02)

K942735 · KHS

Chemistry · 283d

Cleared Mar 13, 1995

SERUM @-HYDROXYBUTYRATE DEHYDROGENASE (HBDH)

K941427 · JMK

Chemistry · 354d

Cleared Oct 04, 1994

MULTI ANALYTE LINEARITY SET

K936245 · JJY

Chemistry · 278d

Cleared Sep 09, 1994

URINE REAGENT STRIP-3 PARAMETERS

K940469 · JIL

Chemistry · 219d

Cleared Apr 15, 1994

ONE STEP PREGNANCY TEST

K936031 · JHI

Chemistry · 119d

Cleared Nov 05, 1993

AMYLASE REAGENT SET (KINETIC)

K931080 · JFJ

Chemistry · 248d