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Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Horiba Abx · Predicate Candidate Screening

19 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

158 daysmedian FDA review time
329 days90th percentile
19clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K073309ABX PENTRA HBA1C WB, CALIBRATOR, CONTROL AND HEMOLYSIS REAGEHoriba Abx2008-10-173290
K081276ABX PENTRA GLUCOSE HK CP, ABX PENTRA URIC ACID CP, ABX PENTRHoriba Abx2008-09-121301
K071779ABX PENTRA URINE CALHoriba Abx2008-03-052470
K072115ABX PENTRA CREATININE 120 CP, TOTAL PROTEIN 100 CP, MULTICALHoriba Abx2007-11-301211
K070146ABX PENTRA GLUCOSE HK CP, UREA CP, URIC ACID CPHoriba Abx2007-10-122690
K062737CARDIAC MARKERS ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZEHoriba Abx2007-06-122720
K060434ABX PENTRA ALBUMIN CP, ABX PENTRA MICRO-ALBUMIN CP, ABX PENTHoriba Abx2007-06-054690
K070249ABX PENTRA 400, CALCIUM CP, CREATININE CP, PHOSPHORUS CP, AMHoriba Abx2007-04-26901
K062180ABX PENTRA AMYLASE CP; MULTICAL; N CONTROL; P CONTROL; CLEANHoriba Abx2006-10-02630
K061138ABX PENTRA 400 : CRPHoriba Abx2006-09-291580
K060854ABX PENTRA 400: LIPOPROTEINSHoriba Abx2006-08-241482
K060325ABX PENTRA BILIRUBIN, DIRECT CP, ABX PENTRA BILIRUBIN, TOTALHoriba Abx2006-08-161880
K060318HEPATIC ENZYMES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZEHoriba Abx2006-08-081811
K060205GENERAL CHEMISTRIES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANAHoriba Abx2006-07-211761
K053308ABX MICROS CRP 200, OPTION IMHoriba Abx2005-12-29311
K052007ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER (OPTION: I.S.E. MHoriba Abx2005-12-161444
K050448CHROMOPEP PC, CHROMOPEP AT, MODELS 2.5 AND 5Horiba Abx2005-09-232130
K050721ABX ERYTROLHoriba Abx2005-06-01720
K050719ABX PENTRA DX 120: OPTION SPS EVOLUTIONHoriba Abx2005-04-26361

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda