FDA applicant

Zygotek Systems, Inc.

Springfield, MA1 decision1986–19860 recalls

FDA records 1 decision for Zygotek Systems, Inc. (Springfield, MA) in 1986: 1 510(k) clearance. All are in product code DGB (Seminal Fluid, Antigen, Antiserum, Control). 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, immunology panel, where it files most

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

FDA decisions per year

No FDA decision for Zygotek Systems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Zygotek”

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

Zygotek Assoc. 1

Zygotek Systems, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Zygotek”