510(k) Report

FDA applicant

Cytotech, Inc.

San Diego, CA10 decisions1986–19883 recalls

FDA records 10 decisions for Cytotech, Inc. (San Diego, CA) from 1986 to 1988: 10 510(k) clearances. Most are in product codes DAK (Complement C1q, Antigen, Antiserum, Control) and LKJ (Antinuclear Antibody, Antigen, Control). 3 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, immunology panel, where it files most

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

FDA decisions per year

No FDA decision for Cytotech, Inc. since 2007.

Recalls per year

1in 2023

2015: 12017: 12023: 1
2007high 1 (2015) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Cytotech, 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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