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FDA 510(k)

IMMUNOMATRIX THEOPHYLINE ASSAY SYSTEM

K-Number: K911060 · 1991-05-08

ApplicantImmunomatrix
Decision Date1991-05-08
Product CodeKLS
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

IMMUNOMATRIX THEOPHYLINE ASSAY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Immunomatrix. It received FDA 510(k) clearance on 1991-05-08 under 510(k) number K911060. 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 IMMUNOMATRIX THEOPHYLINE ASSAY SYSTEM?

IMMUNOMATRIX THEOPHYLINE ASSAY SYSTEM is a medical device that received FDA 510(k) clearance on 1991-05-08. The listed applicant is Immunomatrix. The 510(k) number is K911060.

When did IMMUNOMATRIX THEOPHYLINE ASSAY SYSTEM receive FDA 510(k) clearance?

IMMUNOMATRIX THEOPHYLINE ASSAY SYSTEM received FDA 510(k) clearance on 1991-05-08, under 510(k) number K911060.

Who is the listed applicant for IMMUNOMATRIX THEOPHYLINE ASSAY SYSTEM?

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

What is the FDA product code for IMMUNOMATRIX THEOPHYLINE ASSAY SYSTEM?

The FDA product code for IMMUNOMATRIX THEOPHYLINE ASSAY SYSTEM is KLS.

Related Clinical Trials

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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