FDA applicant
Utak Laboratories, Inc.
FDA records 23 decisions for Utak Laboratories, Inc. (Mchenry, IL) from 1980 to 1991: 23 510(k) clearances. Most are in product codes DIF (Drug Mixture Control Materials) and LAS (Drug Specific Control Materials). 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 Utak Laboratories, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Utak Laboratories, Inc. since 2007.
Recalls per year
1in 2020
Class I Class II/III not classified
Planning a device like Utak Laboratories, 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 “Utak”
FDA records each applicant name separately; these may or may not be the same firm.