510(k) Report

FDA applicant

Greer Laboratories, Inc.

Lenoir, NC2 decisions1989–20000 recalls

FDA records 2 decisions for Greer Laboratories, Inc. (Lenoir, NC) from 1989 to 2000: 2 510(k) clearances. All are in product code SCL (Allergen And Vaccine Delivery Needles). 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, general hospital panel, where it files most

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

FDA decisions per year

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

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Greer Laboratories, 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?

  • SCLAllergen And Vaccine Delivery Needles2decisions

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.

  • K003195Greertrack Skin Testing System, Model GT-IT, GT-ICGreer Laboratories, Inc. · 20001cites it

What has FDA decided for it lately?

  • K003195Greertrack Skin Testing System, Model GT-IT, GT-ICGreer Laboratories, Inc. · 2000
  • K890360Greer Dermapik SystemGreer Laboratories, Inc. · 1989

All 2 as Greer Laboratories, Inc. →