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FDA 510(k)

GREERTRACK SKIN TESTING SYSTEM, MODEL GT-IT, GT-IC

K-Number: K003195 · 2000-12-13

ApplicantGreer Laboratories, Inc.
Decision Date2000-12-13
Product CodeSCL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

GREERTRACK SKIN TESTING SYSTEM, MODEL GT-IT, GT-IC is the device name listed in this FDA 510(k) record. The listed applicant is Greer Laboratories, Inc.. It received FDA 510(k) clearance on 2000-12-13 under 510(k) number K003195. The device is classified under product code SCL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GREERTRACK SKIN TESTING SYSTEM, MODEL GT-IT, GT-IC?

GREERTRACK SKIN TESTING SYSTEM, MODEL GT-IT, GT-IC is a medical device that received FDA 510(k) clearance on 2000-12-13. The listed applicant is Greer Laboratories, Inc.. The 510(k) number is K003195.

When did GREERTRACK SKIN TESTING SYSTEM, MODEL GT-IT, GT-IC receive FDA 510(k) clearance?

GREERTRACK SKIN TESTING SYSTEM, MODEL GT-IT, GT-IC received FDA 510(k) clearance on 2000-12-13, under 510(k) number K003195.

Who is the listed applicant for GREERTRACK SKIN TESTING SYSTEM, MODEL GT-IT, GT-IC?

The FDA 510(k) record lists Greer Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GREERTRACK SKIN TESTING SYSTEM, MODEL GT-IT, GT-IC?

The FDA product code for GREERTRACK SKIN TESTING SYSTEM, MODEL GT-IT, GT-IC is SCL.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Greer Laboratories, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K890360GREER DERMAPIK SYSTEM

Related Devices (Code: SCL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250983Medblue Skin Prick Test Applicator (AS103, AS108, AS109, AS110, AS111, AS113, AS132, AS134, AS146, AS148, AS160, AS162, AS170, AS172)Asistan MedikalK222385Bifurcated NeedleAnhui Tiankang Medical Technology Co., Ltd.K182582Oryum and Ovem Epidermal Deri Prick Test ApplicatorAllergy & Applicator Depot, LLCK172062AllergiEnd ST-9 Multiple Skin Test Applicator, AllergiEnd ST-9 Multiple Well Test TrayMedscience Science Research Group, Inc.K162917Allerhope Allergy Skin TesterProcare Industrial Co., LimitedK032528BD ECLIPSE BIFURCATED NEEDLEBecton, Dickinson & CO

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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