510(k) Report

FDA applicant

Arden Medical Systems, Inc.

Roseville, MN3 decisions1987–19880 recalls

FDA records 3 decisions for Arden Medical Systems, Inc. (Roseville, MN) from 1987 to 1988: 3 510(k) clearances. Most are in product codes JJY (Multi-Analyte Controls, All Kinds (Assayed)) and GKF (Instrument, Hematocrit, Automated). 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 Arden Medical Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Arden Medical Systems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • JJYMulti-Analyte Controls, All Kinds (Assayed)2decisions
  • GKFInstrument, Hematocrit, Automated1decision

What has FDA decided for it lately?

  • K883012A.QC Chemistry Control Level 2Arden Medical Systems, Inc. · 1988
  • K873611A-QC Clinical Chemistry ControlArden Medical Systems, Inc. · 1987
  • K870860Chempro 1000(TM)Arden Medical Systems, Inc. · 1987

All 3 as Arden Medical Systems, Inc. →

Other applicant names beginning “Arden”

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

Arden Sales, Inc. 1Arden Laboratories, Incorporated 1