510(k) Report

FDA applicant

Tissue Culture Innovations

Santa Ana, CA6 decisions1986–19860 recalls

FDA records 6 decisions for Tissue Culture Innovations (Santa Ana, CA) in 1986: 6 510(k) clearances. Most are in product codes KIT (Media And Components, Synthetic Cell And…) and KIP (Formulations, Balanced Salt Solutions). 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, hematology panel, where it files most

How often FDA has decided Tissue Culture Innovations’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Tissue Culture Innovations since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Tissue”

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