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FDA 510(k)

IL TEST THEOPHYLLINE

K-Number: K943979 · 1995-01-18

ApplicantInstrumentation Laboratory CO
Decision Date1995-01-18
Product CodeKLS
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

IL TEST THEOPHYLLINE is the device name listed in this FDA 510(k) record. The listed applicant is Instrumentation Laboratory CO. It received FDA 510(k) clearance on 1995-01-18 under 510(k) number K943979. 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 IL TEST THEOPHYLLINE?

IL TEST THEOPHYLLINE is a medical device that received FDA 510(k) clearance on 1995-01-18. The listed applicant is Instrumentation Laboratory CO. The 510(k) number is K943979.

When did IL TEST THEOPHYLLINE receive FDA 510(k) clearance?

IL TEST THEOPHYLLINE received FDA 510(k) clearance on 1995-01-18, under 510(k) number K943979.

Who is the listed applicant for IL TEST THEOPHYLLINE?

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

What is the FDA product code for IL TEST THEOPHYLLINE?

The FDA product code for IL TEST THEOPHYLLINE is KLS.

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Other records listing Instrumentation Laboratory CO as applicant

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K221359ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgMK223187HemosIL Liquid Anti-XaK223090GEM Premier ChemSTATK223402HemosIL von Willebrand Factor AntigenK213464HemosIL Liquid Anti-XaK213426HemosIL ReadiPlasTin

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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.K013272ACS: 180 AND ADVIA CENTAUR THEOPHYLLINE 2 ASSAYBayer Corp.K011166MODIFICATION TO EMIT 2000 THEOPHYLLINE ASSAY, MODEL OSR 4P229Syva Co., Dade Behring, Inc.

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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