510(k) Report

FDA applicant

Cis Radiopharmaceuticals, Inc.

Mchenry, IL9 decisions1976–19791 recall

FDA records 9 decisions for Cis Radiopharmaceuticals, Inc. (Mchenry, IL) from 1976 to 1979: 9 510(k) clearances. Most are in product codes LEY (Set, Oral Administration) and JNO (N-Benzoyl-L-Arginine Ethyl Ester (U.V.), Trypsin). 1 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 Cis Radiopharmaceuticals, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Cis Radiopharmaceuticals, Inc. since 2007.

Recalls per year

1in 2007

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

Class I Class II/III not classified

FIG. 1 — Cis Radiopharmaceuticals, 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?

  • LEYSet, Oral Administration1decision
  • JNON-Benzoyl-L-Arginine Ethyl Ester (U.V.), Trypsin1decision
  • JLSRadioimmunoassay, Progesterone1decision
  • IWASource, Wire, Iridium, Radioactive1decision
  • CEPRadioimmunoassay, Luteinizing Hormone1decision
  • DBFFerritin, Antigen, Antiserum, Control1decision

Also: CFT (1), DDR (1), CGJ (1).

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K791202Ria Kit for TrypsinCis Radiopharmaceuticals, Inc. · 19791cites it

What has FDA decided for it lately?

  • K791860Ferritin Ria KitCis Radiopharmaceuticals, Inc. · 1979
  • K792063Follicle Stimulating Hormone (FSH) KitCis Radiopharmaceuticals, Inc. · 1979
  • K791202Ria Kit for TrypsinCis Radiopharmaceuticals, Inc. · 19791 recall
  • K792000Luteinizing Hormone (LH) RiaCis Radiopharmaceuticals, Inc. · 1979
  • K791051Progesterone Radioimmunoassay KitCis Radiopharmaceuticals, Inc. · 1979
  • K790003Ria Kit, ProlactinCis Radiopharmaceuticals, Inc. · 1979
  • K780982Kits, Ria, Myoglobin, Human, MeasurementCis Radiopharmaceuticals, Inc. · 1978
  • K771878Iridium 192 Wires & PinsCis Radiopharmaceuticals, Inc. · 1977

All 9 as Cis Radiopharmaceuticals, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K791202DiaSorin TRYPSIK Kits, Catalog Number P2573-(assay used as a procedure for the…Feb 15, 2007