FDA applicant
Analytical Control Systems, Inc.
FDA records 42 decisions for Analytical Control Systems, Inc. (Fishers, IN) from 1979 to 1997: 42 510(k) clearances. Most are in product codes JJY (Multi-Analyte Controls, All Kinds (Assayed)) and GFO (Activated 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 Analytical Control Systems, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Analytical Control Systems, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Analytical Control Systems, Inc.’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 “Analytical”
FDA records each applicant name separately; these may or may not be the same firm.