510(k) Report

FDA applicant

Microscan Div. Baxter Healthcare Corp.

West Sacramento, CA11 decisions1987–19879 recalls

FDA records 11 decisions for Microscan Div. Baxter Healthcare Corp. (West Sacramento, CA) in 1987: 11 510(k) clearances. Most are in product codes GQS (Antigens, Cf (Including Cf Control)…) and GNX (Antigens, Cf (Including Cf Control), Influenza…). 9 recalls are linked to its devices.

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

FIG. A — Illustration, microbiology panel, where it files most

How often FDA has decided Microscan Div. Baxter Healthcare Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Microscan Div. Baxter Healthcare Corp. since 2007.

Recalls per year

8in 2014

2008: 12014: 8
2007high 8 (2014) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Microscan Div. Baxter Healthcare Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Microscan Div. Baxter Healthcare Corp.’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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