FDA applicant

Instrumentation Laboratory (IL) Co.

Bedford, MA5 decisions2024–20260 recalls

FDA records 5 decisions for Instrumentation Laboratory (IL) Co. (Bedford, MA) from 2024 to 2026: 5 510(k) clearances. Most are in product codes GKP (Instrument, Coagulation, Automated) and LCO (Platelet Factor 4 Radioimmunoassay). Its devices cite 5 predicates, 0 of them its own earlier devices. 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 Instrumentation Laboratory (IL) Co.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2025

2024high 2 (2025) · low 1 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2024.

FIG. 1 — Instrumentation Laboratory (IL) Co. by year, 2024–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Instrumentation Laboratory (IL) Co.’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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Other applicant names beginning “Instrumentation”

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

Instrumentation Laboratory CO 327 Instrumentation Industries, Inc. 46 Instrumentation Camera, Inc. 2 Instrumentation Specialties, Inc. 2

Instrumentation Laboratory (IL) Co.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Instrumentation”