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FDA 510(k)

QUINTEST

K-Number: K953939 · 1995-11-13

ApplicantBayer Corp.
Decision Date1995-11-13
Product CodeSCL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

QUINTEST is the device name listed in this FDA 510(k) record. The listed applicant is Bayer Corp.. It received FDA 510(k) clearance on 1995-11-13 under 510(k) number K953939. 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 QUINTEST?

QUINTEST is a medical device that received FDA 510(k) clearance on 1995-11-13. The listed applicant is Bayer Corp.. The 510(k) number is K953939.

When did QUINTEST receive FDA 510(k) clearance?

QUINTEST received FDA 510(k) clearance on 1995-11-13, under 510(k) number K953939.

Who is the listed applicant for QUINTEST?

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

What is the FDA product code for QUINTEST?

The FDA product code for QUINTEST is SCL.

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Other records listing Bayer Corp. 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.

K024062ASCENSIA BREEZE BLOOD GLUCOSE METERK023944BAYER DIAGNOSTICS CLINITEST PREGNANCY TESTK024017BAYER ADVIA CENTAUR HER-2/NEU ASSAYK024234ASCENSIA GLUCOFACTS; ASCENSIA GLUCOFACTS PROFESSIONALK022288COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEMK023584ASCENSIA DEX 2 DIABETES CARE SYSTEM

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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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