510(k) Report

FDA applicant

Immunetech Corporation

Rancho Santa Fe, CA4 decisions2002–20066 recalls

FDA records 4 decisions for Immunetech Corporation (Rancho Santa Fe, CA) from 2002 to 2006: 4 510(k) clearances. Most are in product codes JKA (Tubes, Vials, Systems, Serum Separators, Blood…) and DGC (Ige, Antigen, Antiserum, Control). Its devices cite 3 predicates, 1 of them its own earlier devices. 6 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 Immunetech Corporation’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Immunetech Corporation since 2007.

Recalls per year

6in 2011

2011: 6
2007high 6 (2011) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Immunetech Corporation’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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Which product codes does it file in?

  • JKATubes, Vials, Systems, Serum Separators, Blood Collection2decisions
  • DGCIge, Antigen, Antiserum, Control1decision
  • DHBSystem, Test, Radioallergosorbent (Rast) Immunological1decision

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K020387Myallergytest SystemImmunetech Corporation · 20021cites it

What has FDA decided for it lately?

  • K061979Modification to Myallergy TestImmunetech Corporation · 20066 recalls
  • K032251Immunetech Total Ige SystemImmunetech Corporation · 2003
  • K021698MY Allergy TestImmunetech Corporation · 20026 recalls
  • K020387Myallergytest SystemImmunetech Corporation · 2002

All 4 as Immunetech Corporation →

What has been recalled?

6 recalls linked to its devices; the latest:

  • K021698ImmuneTech brand MyAllergyTest, Specimen Collection Kit, Part No. 8001; Individually…Nov 4, 2011
  • K021698ImmuneTech brand MyAllergyTest, Specimen Collection Kit, Part No. 8013, Provider Pack…Nov 4, 2011
  • K021698ImmuneTech brand MyAllergyTest, Specimen Collection Kit, Part No. 8014, Provider Pack…Nov 4, 2011
  • K021698ImmuneTech brand MyAllergyTest, Specimen Collection Kit, Part No. 8021, Screening Pack…Nov 4, 2011
  • K021698ImmuneTech brand MyAllergyTest, Specimen Collection Kit, Part No. 8024, Provider Pack: 5…Nov 4, 2011
  • K021698ImmuneTech brand MyAllergyTest, Specimen Collection Kit, Part No. 8015, Screening Pack…Nov 4, 2011