Horiba Abx - FDA 510(k) Cleared Devices

Cleared Oct 17, 2008

ABX PENTRA HBA1C WB, CALIBRATOR, CONTROL AND HEMOLYSIS REAGENT

K073309 · LCP

Chemistry · 329d

Cleared Sep 12, 2008

ABX PENTRA GLUCOSE HK CP, ABX PENTRA URIC ACID CP, ABX PENTRA URINE CONTROL L/H

K081276 · CFR

Chemistry · 130d

Cleared Mar 05, 2008

ABX PENTRA URINE CAL

K071779 · JIX

Chemistry · 247d

Cleared Nov 30, 2007

ABX PENTRA CREATININE 120 CP, TOTAL PROTEIN 100 CP, MULTICAL, N AND P...

K072115 · CGX

Chemistry · 121d

Cleared Oct 12, 2007

ABX PENTRA GLUCOSE HK CP, UREA CP, URIC ACID CP

K070146 · CDQ

Chemistry · 269d

Cleared Jun 12, 2007

CARDIAC MARKERS ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER

K062737 · CGS

Chemistry · 272d

Cleared Jun 05, 2007

ABX PENTRA ALBUMIN CP, ABX PENTRA MICRO-ALBUMIN CP, ABX PENTRA TOTAL PROTEIN...

K060434 · CIX

Chemistry · 469d

Cleared Apr 26, 2007

ABX PENTRA 400, CALCIUM CP, CREATININE CP, PHOSPHORUS CP, AMYLASE CP, URINE...

K070249 · CIC

Chemistry · 90d

Cleared Oct 02, 2006

ABX PENTRA AMYLASE CP

K062180 · JFJ

Chemistry · 63d

Cleared Sep 29, 2006

ABX PENTRA 400 : CRP

K061138 · DCK

Chemistry · 158d

Cleared Aug 24, 2006

ABX PENTRA 400: LIPOPROTEINS

K060854 · JIT

Chemistry · 148d

Cleared Aug 16, 2006

ABX PENTRA BILIRUBIN, DIRECT CP, ABX PENTRA BILIRUBIN, TOTAL CP, ABX PENTRA...

K060325 · CIG

Chemistry · 188d

Cleared Aug 08, 2006

HEPATIC ENZYMES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER

K060318 · CIT

Chemistry · 181d

Cleared Jul 21, 2006

GENERAL CHEMISTRIES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER

K060205 · CJE

Chemistry · 176d

Cleared Dec 16, 2005

ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER (OPTION: I.S.E. MODULE)

K052007 · CFR

Chemistry · 144d