GREERTRACK SKIN TESTING SYSTEM, MODEL GT-IT, GT-IC— 510(k) K003195

Name: FDA 510(k) clearance K003195
Creator: U.S. Food and Drug Administration
Published: 2000-12-13

Substantially Equivalent

Greer Laboratories, Inc.

FDA 510(k) clearance K003195 for GREERTRACK SKIN TESTING SYSTEM, MODEL GT-IT, GT-IC, Substantially Equivalent on 2000-12-13. Applicant: Greer Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Greer Laboratories, Inc.
Product code: Code SCL
Device class: Class 2
Regulation: 21 CFR 880.5570
Advisory panel: General Hospital
Date received: 2000-10-12
Decision date: 2000-12-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lenoir, NC, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code SCL

view all

K250983 — Medblue Skin Prick Test Applicator (AS103, AS108, AS109, AS110, AS111, AS113, AS132, AS134, AS146, AS148, AS160, AS162, AS170, AS172)2026-01-30
K222385 — Bifurcated Needle2022-12-06
K182582 — Oryum and Ovem Epidermal Deri Prick Test Applicator2019-04-10
K172062 — AllergiEnd ST-9 Multiple Skin Test Applicator, AllergiEnd ST-9 Multiple Well Test Tray2018-03-05
K162917 — Allerhope Allergy Skin Tester2017-08-17

More clearances from Greer Laboratories, Inc.

view all

K890360 — GREER DERMAPIK SYSTEM1989-06-23

Data sourced from openFDA. This site is unofficial and independent of the FDA.