FDA applicant
Biological & Environmental Control Laboratories
FDA records 20 decisions for Biological & Environmental Control Laboratories (Toledo, OH) from 1982 to 1997: 20 510(k) clearances. Most are in product codes FPA (Set, Administration, Intravascular) and KME (Bedding, Disposable, Medical). Its devices cite 12 predicates, 0 of them its own earlier devices. 1 recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Biological & Environmental Control Laboratories’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Biological & Environmental Control Laboratories since 2007.
Recalls per year
1in 2009
Class I Class II/III not classified
Planning a device like Biological & Environmental Control…’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 “Biological”
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