FDA applicant

Seracare Technology

Austin, TX5 decisions1999–19990 recalls

FDA records 5 decisions for Seracare Technology (Austin, TX) in 1999: 5 510(k) clearances. Most are in product codes JJY (Multi-Analyte Controls, All Kinds (Assayed)) and DIF (Drug Mixture Control Materials). Its devices cite 2 predicates, 0 of them its own earlier devices. 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, clinical chemistry panel, where it files most

How often FDA has decided Seracare Technology’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Seracare Technology since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Seracare Technology

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?