FDA applicant

Franklin Diagnostics, Inc.

Cedar Knolls, NJ2 decisions1989–19960 recalls

FDA records 2 decisions for Franklin Diagnostics, Inc. (Cedar Knolls, NJ) from 1989 to 1996: 2 510(k) clearances. Most are in product codes JLW (Radioimmunoassay, Thyroid-Stimulating Hormone) and FQZ (Thermometer, Clinical Color Change). Its devices cite 1 predicate, 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 Franklin Diagnostics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Franklin Diagnostics, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Franklin Diagnostics, Inc.’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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Other applicant names beginning “Franklin”

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

Franklin Medical USA, Inc. 4 Franklin Sales & Mfg. Co. 2 Franklin M. Din D.M.D., P.A. 1 Franklin Corp. 1 Franklin X-Ray Corp. 1

Franklin Diagnostics, Inc.

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?

Other applicant names beginning “Franklin”