510(k) Report

FDA applicant

Cenogenics Corp.

Morganville, NJ5 decisions1985–20050 recalls

FDA records 5 decisions for Cenogenics Corp. (Morganville, NJ) from 1985 to 2005: 5 510(k) clearances. Most are in product codes JMZ (Comparison Of Freezing Points & Stds. Of Known…) and KTN (System, Test, Infectious Mononucleosis). 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 Cenogenics Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Cenogenics Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Cenogenics 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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