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FDA 510(k)

ROCHE ONLINE THEOPHYLLINE

K-Number: K020740 · 2002-04-16

ApplicantRoche Diagnostics Corp.
Decision Date2002-04-16
Product CodeKLS
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ROCHE ONLINE THEOPHYLLINE is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics Corp.. It received FDA 510(k) clearance on 2002-04-16 under 510(k) number K020740. 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 ROCHE ONLINE THEOPHYLLINE?

ROCHE ONLINE THEOPHYLLINE is a medical device that received FDA 510(k) clearance on 2002-04-16. The listed applicant is Roche Diagnostics Corp.. The 510(k) number is K020740.

When did ROCHE ONLINE THEOPHYLLINE receive FDA 510(k) clearance?

ROCHE ONLINE THEOPHYLLINE received FDA 510(k) clearance on 2002-04-16, under 510(k) number K020740.

Who is the listed applicant for ROCHE ONLINE THEOPHYLLINE?

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

What is the FDA product code for ROCHE ONLINE THEOPHYLLINE?

The FDA product code for ROCHE ONLINE THEOPHYLLINE is KLS.

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Other records listing Roche Diagnostics 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.

K130138SUPER SANI-CLOTH/ ACCU-CHEK INFORM II SYSTEMK101365ELECSYS CA 19-9 CALCHECK 5K100853COBAS 8000 MODULAR SERIES ANALYZERK101196ACCU-CHEK ULTRFLEX INFUSION SETK093664AMPHETAMINES II ASSAYK101075ELECSYS INSULIN CALCHECK 5

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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.K011771RANDOX THEOPHYLLINERandox Laboratories, Ltd.K013272ACS: 180 AND ADVIA CENTAUR THEOPHYLLINE 2 ASSAYBayer Corp.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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