FDA applicant

Biotek Solutions, Inc.

Santa Barbara, CA6 decisions1995–19960 recalls

FDA records 6 decisions for Biotek Solutions, Inc. (Santa Barbara, CA) from 1995 to 1996: 6 510(k) clearances. Most are in product codes DEH (Lambda, Antigen, Antiserum, Control) and DFH (Kappa, 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 Biotek Solutions, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Biotek Solutions, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Biotek Solutions, 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 “Biotek”

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

Biotek-Caribbean 1

Biotek Solutions, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Biotek”