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

Hematology Marketing Assoc. — Predicate Candidate Screening

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

77 daysmedian FDA review time

95 days90th percentile

14clearances measured

K-number	Device	Applicant	Decided	Review days
K851843	OSMOCEL 3	Hematology Marketing Assoc.	1985-07-30	95
K851375	TRI-COUNT	Hematology Marketing Assoc.	1985-07-12	95
K850096	LASER-GLOBIN	Hematology Marketing Assoc.	1985-03-29	77
K850095	LASER-DIL	Hematology Marketing Assoc.	1985-03-29	77
K850094	LASER-GLOBIN POWDER	Hematology Marketing Assoc.	1985-03-29	77
K850097	LASER-LYSE	Hematology Marketing Assoc.	1985-03-29	77
K844708	TRI-COUNT CALIBRATOR	Hematology Marketing Assoc.	1985-03-05	92
K843485	TRI-COUNT LASER	Hematology Marketing Assoc.	1984-12-12	97
K834371	TRI-COUNT 10	Hematology Marketing Assoc.	1984-03-09	87
K833130	TRI-COUNT 7	Hematology Marketing Assoc.	1983-10-20	37
K831306	HEMACAL	Hematology Marketing Assoc.	1983-06-16	55
K830188	OSMOCEL +	Hematology Marketing Assoc.	1983-03-01	41
K830187	FOCUS FLUID	Hematology Marketing Assoc.	1983-03-01	41
K830186	LYSIS +	Hematology Marketing Assoc.	1983-02-28	40

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