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FDA 510(k)

QUANTI-TEST SYSTEM

K-Number: K982578 · 1998-09-02

ApplicantPanatrex, Inc.
Decision Date1998-09-02
Product CodeSCL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

QUANTI-TEST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Panatrex, Inc.. It received FDA 510(k) clearance on 1998-09-02 under 510(k) number K982578. 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 QUANTI-TEST SYSTEM?

QUANTI-TEST SYSTEM is a medical device that received FDA 510(k) clearance on 1998-09-02. The listed applicant is Panatrex, Inc.. The 510(k) number is K982578.

When did QUANTI-TEST SYSTEM receive FDA 510(k) clearance?

QUANTI-TEST SYSTEM received FDA 510(k) clearance on 1998-09-02, under 510(k) number K982578.

Who is the listed applicant for QUANTI-TEST SYSTEM?

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

What is the FDA product code for QUANTI-TEST SYSTEM?

The FDA product code for QUANTI-TEST SYSTEM 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 Panatrex, 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.

K042950VAG O SPECULUM, MODELS VS1, VM1, VL1

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

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

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