FDA applicant

Alko Diagnostic Corp.

Holliston, MA31 decisions1982–20000 recalls

FDA records 31 decisions for Alko Diagnostic Corp. (Holliston, MA) from 1982 to 2000: 31 510(k) clearances. Most are in product codes JIX (Calibrator, Multi-Analyte Mixture) and KRZ (Calibrator For Hemoglobin And Hematocrit…). 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, clinical chemistry panel, where it files most

How often FDA has decided Alko Diagnostic Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Alko Diagnostic Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Alko Diagnostic Corp.’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

Other applicant names beginning “Alko”

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

Alko Scientific Co. 2

Alko Diagnostic Corp.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Alko”