510(k) Report

FDA applicant

Hematology Marketing Assoc.

Concord, CA14 decisions1983–19850 recalls

FDA records 14 decisions for Hematology Marketing Assoc. (Concord, CA) from 1983 to 1985: 14 510(k) clearances. Most are in product codes JPK (Mixture, Hematology Quality Control) and GIF (Diluent, Blood Cell). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, hematology panel, where it files most

How often FDA has decided Hematology Marketing Assoc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Hematology Marketing Assoc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Hematology Marketing Assoc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Hematology Marketing Assoc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report