FDA applicant
Bio/Data Corp.
FDA records 37 decisions for Bio/Data Corp. (Mchenry, IL) from 1977 to 2000: 37 510(k) clearances. Most are in product codes JPA (System, Multipurpose For In Vitro Coagulation…) and GGW (Test, Time, Partial Thromboplastin). No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Bio/Data Corp.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Bio/Data Corp. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Bio/Data Corp.’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) Report