510(k) Report

FDA applicant

Proteins Intl., Inc.

Rochester Hills, MI54 decisions1992–19960 recalls

FDA records 54 decisions for Proteins Intl., Inc. (Rochester Hills, MI) from 1992 to 1996: 54 510(k) clearances. Most are in product codes KIR (Cells, Animal And Human, Cultured) and JSN (Culture Media, Propagating Transport). 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, hematology panel, where it files most

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

FDA decisions per year

No FDA decision for Proteins Intl., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Proteins Intl., 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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