Biokit, S.A. - FDA 510(k) Cleared Devices

Cleared Feb 11, 2016

ARCHITECT SHBG

K152185 · CDZ

Chemistry · 190d

Cleared Dec 19, 2013

LP(A) CALIBRATORS, AND LP(A) CONTROLS

K132400 · JIT

Chemistry · 140d

Cleared Nov 23, 2011

ARCHITECT 25-OH VITAMIN D 100T, VITAMIN D 500T, VITAMIN D CALIBRATORS,...

K110619 · MRG

Chemistry · 265d

Cleared Sep 03, 2008

ARCHITECT C-PEPTIDE CALIBRATORS, AND ARCHITECT C-PEPTIDE CONTROLS, MODELS...

K082141 · JIT

Chemistry · 35d

Cleared Jun 19, 2007

ARCHITECT INTACT PTH REAGENTS, CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM,...

K063232 · CEW

Chemistry · 237d

Cleared Jan 23, 2007

ARCHITECT SHBG REAGENT KIT, ARCHITECT SHBG CALIBRATOR KIT, AND ARCHITECT SHBG...

K060818 · CDZ

Chemistry · 302d

Cleared Jan 26, 2006

ARCHITECT DHEA-S CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM AND HIGH)

K060027 · JJX

Chemistry · 22d

Cleared Apr 26, 2005

QUANTIA LA(A)

K050487 · DFC

Chemistry · 60d