510(k) Report

FDA applicant

Optical Diagnostics, Inc.

Issaquah, WA1 decision2001–20010 recalls

FDA records 1 decision for Optical Diagnostics, Inc. (Issaquah, WA) in 2001: 1 510(k) clearance. All are in product code HJT (Haploscope). 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, ophthalmic panel, where it files most

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

FDA decisions per year

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

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Optical 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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Other applicant names beginning “Optical”

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