510(k) Report

FDA applicant

Sangui Biotech, Inc.

Santa Ana, CA5 decisions1997–20002 recalls

FDA records 5 decisions for Sangui Biotech, Inc. (Santa Ana, CA) from 1997 to 2000: 5 510(k) clearances. Most are in product codes CKG (Radioimmunoassay, Acth) and CEW (Radioimmunoassay, Parathyroid Hormone). 2 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, clinical chemistry panel, where it files most

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

FDA decisions per year

No FDA decision for Sangui Biotech, Inc. since 2007.

Recalls per year

1in 2016

2014: 12016: 1
2007high 1 (2014) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Sangui Biotech, 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?

  • CKGRadioimmunoassay, Acth1decision
  • CEWRadioimmunoassay, Parathyroid Hormone1decision
  • GGTAssay, Erythropoietin1decision
  • JKRRadioimmunoassay, Calcitonin1decision
  • NAOTest, Carbohydrate Deficient Transferrin1decision

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.

  • K992799Sangui Biotech, Inc. Epo (Erythropoietin) Elisa KitSangui Biotech, Inc. · 20001cites it

What has FDA decided for it lately?

  • K001943Chronalco I.D.CDT (Carbohydrate Deficient Transferrin) AssaySangui Biotech, Inc. · 2000
  • K992799Sangui Biotech, Inc. Epo (Erythropoietin) Elisa KitSangui Biotech, Inc. · 2000
  • K982491Sangui Biotech, Inc. Calcitonin Elisa KitSangui Biotech, Inc. · 19981 recall
  • K982608Sangui Biotech, Inc. Acth (Adrenocorticotropic Hormone) Elisa KitSangui Biotech, Inc. · 1998
  • K974306Sangui Biotech, Inc. Intact-PTH (Parathyroid Hormone) ElisaSangui Biotech, Inc. · 19971 recall

All 5 as Sangui Biotech, Inc. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K974306Quidel MicroVue Intact PTH EIA, Model 8044. An enzyme immunoassay for the quantification…Oct 26, 2016Class III
  • K982491Calcitonin ELISA Kit, Code No. 7024, 7024BU. Intended use of this product is the…Sep 18, 2014Class II