510(k) Report

FDA applicant

Intercare Diagnostics, Inc.

Baltimore, MD5 decisions1986–19940 recalls

FDA records 5 decisions for Intercare Diagnostics, Inc. (Baltimore, MD) from 1986 to 1994: 5 510(k) clearances. Most are in product codes LSQ (Reagent, Rickettsia Serological) and HCC (Device, Biofeedback). 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, microbiology panel, where it files most

How often FDA has decided Intercare Diagnostics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Intercare Diagnostics, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Intercare Diagnostics, Inc.’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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