510(k) Report

FDA applicant

Candace Lane Corp.

Parsippany, NJ1 decision1987–19870 recalls

FDA records 1 decision for Candace Lane Corp. (Parsippany, NJ) in 1987: 1 510(k) clearance. All are in product code KIS (Sera, Animal And Human). 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 Candace Lane Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Candace Lane Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Candace Lane 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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