510(k) Report

FDA applicant

Biosafe Laboratories, Inc.

Lake Forest, IL6 decisions1999–20040 recalls

FDA records 6 decisions for Biosafe Laboratories, Inc. (Lake Forest, IL) from 1999 to 2004: 6 510(k) clearances. Most are in product codes JLW (Radioimmunoassay, Thyroid-Stimulating Hormone) and LCP (Assay, Glycosylated Hemoglobin). Its devices cite 7 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 Biosafe Laboratories, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Biosafe Laboratories, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Biosafe Laboratories, Inc.’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?

  • JLWRadioimmunoassay, Thyroid-Stimulating Hormone2decisions
  • LCPAssay, Glycosylated Hemoglobin1decision
  • CHHEnzymatic Esterase--Oxidase, Cholesterol1decision
  • JKATubes, Vials, Systems, Serum Separators, Blood Collection1decision
  • KHGWhole Blood Hemoglobin Determination1decision

Whose devices does it build on?

Its devices cite 7 predicates; 0 are its own earlier devices. The firms it cites most:

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.

  • K012221Safe at Home Cholesterol Profile Blood Collection and Transport SystemBiosafe Laboratories, Inc. · 20021cites it
  • K042379Anemiapro Self-ScreenerBiosafe Laboratories, Inc. · 20041cites it

What has FDA decided for it lately?

  • K042379Anemiapro Self-ScreenerBiosafe Laboratories, Inc. · 2004
  • K012221Safe at Home Cholesterol Profile Blood Collection and Transport SystemBiosafe Laboratories, Inc. · 2002
  • K011970Biosafe Cholesterol Profile Blood Collection and Transport SystemBiosafe Laboratories, Inc. · 2001
  • K011525Safe at Home TSH (Thyroid Stimulating Hormone Blood Collection and Transport System)Biosafe Laboratories, Inc. · 2001
  • K003752Biosafe Capillary Blood Transport System for Testing Thyroid Stimulating Hormone (TSH)Biosafe Laboratories, Inc. · 2001
  • K991850Safe at-Home Test Kit for Monitoring Hemoglobin AlcBiosafe Laboratories, Inc. · 1999

All 6 as Biosafe Laboratories, Inc. →