510(k) Report

FDA applicant

Probe-Tek, Inc.

Lansing, MI2 decisions1987–19881 recall

FDA records 2 decisions for Probe-Tek, Inc. (Lansing, MI) from 1987 to 1988: 2 510(k) clearances. Most are in product codes JBR (Test, Heparin Neutralization) and JPA (System, Multipurpose For In Vitro Coagulation…). 1 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 Probe-Tek, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Probe-Tek, Inc. since 2007.

Recalls per year

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Probe-Tek, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Probe-Tek”

FDA records each applicant name separately; these may or may not be the same firm.