510(k) Report

FDA applicant

Substance Abuse Specialties, Inc.

Research Triangle Park, NC1 decision1997–19970 recalls

FDA records 1 decision for Substance Abuse Specialties, Inc. (Research Triangle Park, NC) in 1997: 1 510(k) clearance. All are in product code KDW (Container, Specimen Mailer And Storage…). 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, pathology panel, where it files most

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

FDA decisions per year

No FDA decision for Substance Abuse Specialties, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • KDWContainer, Specimen Mailer And Storage, Temperature Controlled, Sterile1decision

What has FDA decided for it lately?

  • K970580Sasi-DC1TSSubstance Abuse Specialties, Inc. · 1997

The one decision as Substance Abuse Specialties, Inc. →