Horiba Abx is one of 174 FDA 510(k) medical device manufacturers from France in the dataset, ranked by real submission volume.
Horiba Abx - FDA 510(k) Cleared Devices
19
Total
19
Cleared
0
Denied
Horiba Abx has 19 FDA 510(k) cleared chemistry devices. Based in Montpellier, FR.
Historical record: 19 cleared submissions from 2005 to 2008.
Browse the complete list of FDA 510(k) cleared chemistry devices from this manufacturer. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Horiba Abx
19 devices
Cleared
Oct 17, 2008
ABX PENTRA HBA1C WB, CALIBRATOR, CONTROL AND HEMOLYSIS REAGENT
Chemistry
329d
Cleared
Sep 12, 2008
ABX PENTRA GLUCOSE HK CP, ABX PENTRA URIC ACID CP, ABX PENTRA URINE CONTROL L/H
Chemistry
130d
Cleared
Mar 05, 2008
ABX PENTRA URINE CAL
Chemistry
247d
Cleared
Nov 30, 2007
ABX PENTRA CREATININE 120 CP, TOTAL PROTEIN 100 CP, MULTICAL, N AND P...
Chemistry
121d
Cleared
Oct 12, 2007
ABX PENTRA GLUCOSE HK CP, UREA CP, URIC ACID CP
Chemistry
269d
Cleared
Jun 12, 2007
CARDIAC MARKERS ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER
Chemistry
272d
Cleared
Jun 05, 2007
ABX PENTRA ALBUMIN CP, ABX PENTRA MICRO-ALBUMIN CP, ABX PENTRA TOTAL PROTEIN...
Chemistry
469d
Cleared
Apr 26, 2007
ABX PENTRA 400, CALCIUM CP, CREATININE CP, PHOSPHORUS CP, AMYLASE CP, URINE...
Chemistry
90d
Cleared
Oct 02, 2006
ABX PENTRA AMYLASE CP
Chemistry
63d
Cleared
Sep 29, 2006
ABX PENTRA 400 : CRP
Chemistry
158d
Cleared
Aug 24, 2006
ABX PENTRA 400: LIPOPROTEINS
Chemistry
148d
Cleared
Aug 16, 2006
ABX PENTRA BILIRUBIN, DIRECT CP, ABX PENTRA BILIRUBIN, TOTAL CP, ABX PENTRA...
Chemistry
188d