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

Abx Diagnostics — Predicate Candidate Screening

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

58 daysmedian FDA review time

80 days90th percentile

10clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K030799	MICROS 60	Abx Diagnostics	2003-04-08	26	0
K030144	MODIFICATION TO PENTRA 60 AND PENTRA 60C+	Abx Diagnostics	2003-01-31	16	0
K024002	PENTRA 80	Abx Diagnostics	2003-01-03	30	2
K022200	PENTRA 120/PENTRA 120 RETIC OPTIONS SPS, MODEL PENTRA 120	Abx Diagnostics	2002-07-29	24	2
K014203	ABX MICROS 60 HEMATOLOGY ANALYZER	Abx Diagnostics	2002-02-28	69	0
K003677	ABX PENTRA 60C+ HEMATOLOGY ANALYZER	Abx Diagnostics	2000-12-26	27	2
K002646	ABX MICROS CRP	Abx Diagnostics	2000-10-26	63	0
K992511	ABX PENTRA 60 HEMATOLOGY ANALYZER	Abx Diagnostics	1999-10-15	80	1
K991839	ABX PENTRA 120 RETIC AUTOMATED HEMATOLOGY ANALYZER	Abx Diagnostics	1999-08-11	75	0
K990311	VEGA RETIC AUTOMATED HEMATOLOGY ANALYZER	Abx Diagnostics	1999-03-31	58	0

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