510(k) Report

FDA applicant

Rochdiag

Indianapolis, IN3 decisions2001–20070 recalls

FDA records 3 decisions for Rochdiag (Indianapolis, IN) from 2001 to 2007: 3 510(k) clearances. Most are in product codes JIX (Calibrator, Multi-Analyte Mixture) and DEM (Alpha-1-Antitrypsin, Antigen, Antiserum, Control). Its devices cite 2 predicates, 0 of them its own earlier devices. 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 Rochdiag’s devices, and how often a recall has named them.

FDA decisions per year

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Rochdiag 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?

  • JIXCalibrator, Multi-Analyte Mixture1decision
  • DEMAlpha-1-Antitrypsin, Antigen, Antiserum, Control1decision
  • CIGDiazo Colorimetry, Bilirubin1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K063744Cobas Integra C 111Rochdiag · 20074cite it
  • K011658Calibrator for Automated Systems (C.F.a.S.) LipidsRochdiag · 20011cites it

What has FDA decided for it lately?

  • K063744Cobas Integra C 111Rochdiag · 2007
  • K011658Calibrator for Automated Systems (C.F.a.S.) LipidsRochdiag · 2001
  • K010978Tina-Quant Alpha-1 AntitrypsinRochdiag · 2001

All 3 as Rochdiag →