Biomerieux Vitek, Inc. - FDA 510(k) Cleared Devices

Cleared Aug 30, 1996

VIDAS CREATINE KINASE MB ASSAY 30-421

K962549 · JHX

Chemistry · 63d

Cleared Feb 06, 1996

VIDAS ESTRADIOL II (E2II) ASSAY

K955647 · CHP

Chemistry · 56d

Cleared Nov 02, 1994

ENZYME-LINKED FLUORESCENT IMMUNOASSAY

K943811 · CFT

Chemistry · 89d

Cleared Mar 22, 1994

VIDAS T3 ASSAY

K934764 · CDP

Chemistry · 169d

Cleared Mar 22, 1994

VIDAS T UPTAKE

K935816 · KHQ

Chemistry · 110d

Cleared Jul 27, 1993

VIDAS CORTISOL (CORT) ASSAY & SERUM FREE DILUTENT

K931031 · JFT

Chemistry · 148d

Cleared May 13, 1993

VIDAS THYROXINE (T4) ASSAY (T4)

K926393 · KLI

Chemistry · 143d

Cleared Mar 23, 1993

VITEK RAPID CALL-GRAM POSITIVE IDENTIFICATION CARD

K925916 · LQL

Chemistry · 120d

Cleared Feb 12, 1993

MINIVIDAS INSTRUMENT

K923579 · JJE

Chemistry · 207d

Cleared Feb 12, 1993

VIDAS ESTRADIOL (E2) ASSAY

K925498 · CHP

Chemistry · 105d

Cleared Nov 30, 1992

VIDAS FREE THYROXINE(FT4) ASSAY

K925177 · CEC

Chemistry · 47d

Cleared Jun 18, 1992

VITEK IMMUN ASSAY SYS(VIDAS) THYROI STIM HOR ASSAY

K921816 · JLW

Chemistry · 64d

Cleared Jun 16, 1992

VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM

K921746 · CGJ

Chemistry · 64d