Syva Co. - FDA 510(k) Cleared Devices

Cleared Aug 03, 2001

EMIT II PLUS MONOCLONAL AMPHETAMINE/METHAMPHETAMINE ASSAY MODEL OSR9C229

K012257 · DKZ

Chemistry · 16d

Cleared Jun 06, 2001

EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229

K011528 · DLZ

Chemistry · 20d

Cleared Jan 20, 2000

SYVA EMIT II PLUS METHADONE ASSAY, MODELS 9E029UL/9E129UL

K994005 · DJR

Chemistry · 57d

Cleared Jun 01, 1995

EMIT 2000 DIGOXIN ASSAY

K951755 · KXT

Chemistry · 45d

Cleared Mar 24, 1995

EMIT IIC CALIBRATORS

K935192 · DKB

Chemistry · 514d

Cleared Sep 20, 1994

EMIT 2000 DIGOXIN ASSAY/CALIBRATORS

K942619 · LFM

Chemistry · 117d

Cleared Aug 15, 1994

VISTA B12 ASSAY

K941235 · CDD

Chemistry · 153d

Cleared Oct 22, 1993

VISTA FOLATE ASSAY

K934121 · CGN

Chemistry · 58d

Cleared May 26, 1993

VISTA(R) HUMAN LUTEINIZING HORMONE(HLH) ASSAY

K926394 · CEP

Chemistry · 156d

Cleared Mar 29, 1993

VISTA PROLACTIN ASSAY

K926386 · CFT

Chemistry · 97d

Cleared Feb 17, 1993

VISTA(R) HUMAN CHORIONIC GONADOTROPIN (HCG) ASSAY

K926342 · JHI

Chemistry · 62d

Cleared Nov 16, 1992

VISTA FREE THYROXINE ASSAY

K923572 · CEC

Chemistry · 122d