FDA applicant

Alpha-Tec Systems, Inc.

Irvine, CA18 decisions1983–20060 recalls

FDA records 18 decisions for Alpha-Tec Systems, Inc. (Irvine, CA) from 1983 to 2006: 18 510(k) clearances. Most are in product codes JTS (Stains, Microbiologic) and LJG (Quality Control Slides). 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, microbiology panel, where it files most

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

FDA decisions per year

No FDA decision for Alpha-Tec Systems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Alpha-Tec 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 “Alpha-Tec”

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

Alpha Unlimited, Inc. 10 Alpha Omega Engineering, Ltd. 9 Alpha-Omega Services, Inc. 9 Alpha Therapeutic Corp. 8 Alpha-Dent 6 Alpha Omega, Ltd. 5 Alpha Gamma Laboratory 4 Alpha-Bio Tec, Ltd. 4 Alpha Orthopaedics 3 Alpha Surgical, Inc. 2 Alpha Medical Systems 2 Alpha Dent Implants GmbH 2

Alpha-Tec Systems, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Alpha-Tec”