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FDA 510(k)

IL TEST THEOPHYLLINE ASSAY

K-Number: K853858 · 1985-10-15

ApplicantAllied Instrumentation Laboratory
Decision Date1985-10-15
Product CodeKLS
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

IL TEST THEOPHYLLINE ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Allied Instrumentation Laboratory. It received FDA 510(k) clearance on 1985-10-15 under 510(k) number K853858. 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 ASSAY?

IL TEST THEOPHYLLINE ASSAY is a medical device that received FDA 510(k) clearance on 1985-10-15. The listed applicant is Allied Instrumentation Laboratory. The 510(k) number is K853858.

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

IL TEST THEOPHYLLINE ASSAY received FDA 510(k) clearance on 1985-10-15, under 510(k) number K853858.

Who is the listed applicant for IL TEST THEOPHYLLINE ASSAY?

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

What is the FDA product code for IL TEST THEOPHYLLINE ASSAY?

The FDA product code for IL TEST THEOPHYLLINE ASSAY is KLS.

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Other records listing Allied Instrumentation Laboratory 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.

K861901MULTI-4 CO-OXIMETER CONTROLK860365PHENOBARBITAL TEST SYSTEMK860286IL TEST PHENYTOINK852676IL SYSTEM 1304 & 1306, PH/BLOOD GAS ANALYZERSK851933CLINICAL CHEMISTRY ANALYTICAL SYSTEMK850748I-L TEST, DIRECT BILIRUBIN SET

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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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