510(k) Report

FDA applicant

Bay Area Hema. Onco. Clinic. & Res. L

Mchenry, IL4 decisions1977–19770 recalls

FDA records 4 decisions for Bay Area Hema. Onco. Clinic. & Res. L (Mchenry, IL) in 1977: 4 510(k) clearances. Most are in product codes JBQ (Antithrombin Iii Quantitation) and JBR (Test, Heparin Neutralization). 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 Bay Area Hema. Onco. Clinic. & Res. L’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Bay Area Hema. Onco. Clinic. & Res. L since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Bay Area Hema. Onco. Clinic. & Res. L by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Bay Area Hema. Onco. Clinic. & Res. L’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • JBQAntithrombin Iii Quantitation1decision
  • JBRTest, Heparin Neutralization1decision
  • JOZSystem, Automated Platelet Aggregation1decision
  • JBZStudy, Platelet Adhesive1decision

What has FDA decided for it lately?

  • K771678Thrombo-Screen Platelet AdhesionBay Area Hema. Onco. Clinic. & Res. L · 1977
  • K770722Thrombo Screen Quantitative Heparin AssaBay Area Hema. Onco. Clinic. & Res. L · 1977
  • K770394Thrombo-Screen at-111 KitBay Area Hema. Onco. Clinic. & Res. L · 1977
  • K770395Thrombo-Cetin (Ristocetin)Bay Area Hema. Onco. Clinic. & Res. L · 1977

All 4 as Bay Area Hema. Onco. Clinic. & Res. L →