510(k) Report

FDA applicant

Phoenix Biotech Corp.

East Stroudsburg, PA2 decisions2000–20063 recalls

FDA records 2 decisions for Phoenix Biotech Corp. (East Stroudsburg, PA) from 2000 to 2006: 2 510(k) clearances. All are in product code LIP (Enzyme Linked Immunoabsorption Assay…). 3 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, microbiology panel, where it files most

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

FDA decisions per year

No FDA decision for Phoenix Biotech Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Phoenix Biotech Corp. 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?

  • LIPEnzyme Linked Immunoabsorption Assay, Treponema Pallidum2decisions

Who builds on its devices?

Later devices cite its devices 2 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.

  • K001552Trepchek Treponemal Antibody EiaPhoenix Biotech Corp. · 20002cite it

What has FDA decided for it lately?

  • K053570Trep-Sure Treponemal Antibody EiaPhoenix Biotech Corp. · 2006
  • K001552Trepchek Treponemal Antibody EiaPhoenix Biotech Corp. · 20003 recalls

All 2 as Phoenix Biotech Corp. →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K001552Trep-Chek Syphilis Test Kit, 960 tests, Catalog No. TP-960, Distributed by DiaSorin…Mar 16, 2005
  • K001552Product is packaged in a box and is labeled: Syphilis TREP-CHEK No. 720-100-10, 960…Dec 9, 2003
  • K001552The Is-Syphilis TREP-CHEK (TM) Test Kit is a confirmatory in vitro enzyme immunoassay…Sep 11, 2003

Other applicant names beginning “Phoenix”

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

Phoenix Diagnostics, Inc. 21Phoenix Biomedical Corp. 13Phoenix Medical Technology, Inc. 11Phoenix Glove Co. 6Phoenix Dental, Inc. 5Phoenix Bioengineering, Inc. 3Phoenix Medical Devices, LLC 2Phoenix Innovative Healthcare Manufacturers Pvt., Ltd. 2Phoenix Imaging 2Phoenix Surgical Products, Inc. 1Phoenix Management, Inc. 1Phoenix U.V.A., Ltd. 1