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FDA 510(k)

ACS: 180 AND ADVIA CENTAUR THEOPHYLLINE 2 ASSAY

K-Number: K013272 · 2001-10-25

ApplicantBayer Corp.
Decision Date2001-10-25
Product CodeKLS
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ACS: 180 AND ADVIA CENTAUR THEOPHYLLINE 2 ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Bayer Corp.. It received FDA 510(k) clearance on 2001-10-25 under 510(k) number K013272. The device is classified under product code KLS. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACS: 180 AND ADVIA CENTAUR THEOPHYLLINE 2 ASSAY?

ACS: 180 AND ADVIA CENTAUR THEOPHYLLINE 2 ASSAY is a medical device that received FDA 510(k) clearance on 2001-10-25. The listed applicant is Bayer Corp.. The 510(k) number is K013272.

When did ACS: 180 AND ADVIA CENTAUR THEOPHYLLINE 2 ASSAY receive FDA 510(k) clearance?

ACS: 180 AND ADVIA CENTAUR THEOPHYLLINE 2 ASSAY received FDA 510(k) clearance on 2001-10-25, under 510(k) number K013272.

Who is the listed applicant for ACS: 180 AND ADVIA CENTAUR THEOPHYLLINE 2 ASSAY?

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 ACS: 180 AND ADVIA CENTAUR THEOPHYLLINE 2 ASSAY?

The FDA product code for ACS: 180 AND ADVIA CENTAUR THEOPHYLLINE 2 ASSAY is KLS.

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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: KLS)

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.

K042520VITROS CHEMISTRY PRODUCTS CAFFN REAGENT KIT AND TDM PERFORMANCE VERIFIERS I, II AND IIIOrtho-Clinical Diagnostics, Inc.K042407EMIT CAFFEINE ASSAYDade Behring, Inc.K020740ROCHE ONLINE THEOPHYLLINERoche Diagnostics Corp.K011771RANDOX THEOPHYLLINERandox Laboratories, Ltd.K011166MODIFICATION TO EMIT 2000 THEOPHYLLINE ASSAY, MODEL OSR 4P229Syva Co., Dade Behring, Inc.K993029ABBOTT AEROSET THEOPHYLLINE ASSAY AND CALIBRATORS; MODELS 1E09 AND 6E89Syva 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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