510(k) Report

FDA applicant

Biomaterials International, Inc.

Salt Lake City, UT1 decision1986–19860 recalls

FDA records 1 decision for Biomaterials International, Inc. (Salt Lake City, UT) in 1986: 1 510(k) clearance. All are in product code JJQ (Colorimeter, Photometer, Spectrophotometer For…). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, clinical chemistry panel, where it files most

How often FDA has decided Biomaterials International, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Biomaterials International, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Biomaterials International, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Biomaterials International, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Other applicant names beginning “Biomaterials”

FDA records each applicant name separately; these may or may not be the same firm.