510(k) Report

FDA applicant

Btc Corp.

Suisun, CA1 decision1989–19890 recalls

FDA records 1 decision for Btc Corp. (Suisun, CA) in 1989: 1 510(k) clearance. All are in product code LKI (Antisera, Fluorescent, Chlamydia Spp.). 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, microbiology panel, where it files most

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

FDA decisions per year

No FDA decision for Btc Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Btc Corp.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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