510(k) Report

FDA applicant

Tissue Culture Biotec, Inc.

Bozeman, MT1 decision1993–19930 recalls

FDA records 1 decision for Tissue Culture Biotec, Inc. (Bozeman, MT) in 1993: 1 510(k) clearance. All are in product code DHN (Antinuclear Antibody, Indirect…). 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 Tissue Culture Biotec, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Tissue Culture Biotec, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Tissue Culture Biotec, 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?

  • DHNAntinuclear Antibody, Indirect Immunofluorescent, Antigen, Control1decision

What has FDA decided for it lately?

  • K926114Hep-2 Antinuclear Antibody Test SystemTissue Culture Biotec, Inc. · 1993

The one decision as Tissue Culture Biotec, Inc. →

Other applicant names beginning “Tissue”

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

Tissue Technologies, Inc. 9Tissue Culture Innovations 6Tissue Science Laboratories, Plc 6Tissue Regeneration Technologies, LLC 5Tissue Technologies Holdings, LLC 2Tissue Seal, LLC 1Tissue Regenix Group Plc 1Tissue Medical Lasers, Inc. 1Tissue Regeneration Technologies, LLC Dba AS Softwave… 1Tissue Culture Biologicals 1Tissue Differentiation Intelligence, LLC 1Tissue Repair Company 1