FDA applicant
Johnson & Johnson Clinical Diagnostics, Inc.
FDA records 33 decisions for Johnson & Johnson Clinical Diagnostics, Inc. (Rochester, NY) from 1995 to 1998: 33 510(k) clearances. Most are in product codes JJY (Multi-Analyte Controls, All Kinds (Assayed)) and DHA (System, Test, Human Chorionic Gonadotropin). 37 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Johnson & Johnson Clinical Diagnostics, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Johnson & Johnson Clinical Diagnostics, Inc. since 2007.
Recalls per year
3in 2025
Class I Class II/III not classified
Planning a device like Johnson & Johnson Clinical…’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Johnson”
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