FDA 510(k)

KALLESTAD QUANTIZYME THEOPHYLLINE ENZYME

K-Number: K821154 · 1982-05-13

Decision Date1982-05-13

Product CodeKLS

Advisory CommitteeTX

DecisionSubstantially Equivalent

Device Summary

KALLESTAD QUANTIZYME THEOPHYLLINE ENZYME is the device name listed in this FDA 510(k) record. The listed applicant is Jay Rau, Technical Suppprt. It received FDA 510(k) clearance on 1982-05-13 under 510(k) number K821154. 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 KALLESTAD QUANTIZYME THEOPHYLLINE ENZYME?

KALLESTAD QUANTIZYME THEOPHYLLINE ENZYME is a medical device that received FDA 510(k) clearance on 1982-05-13. The listed applicant is Jay Rau, Technical Suppprt. The 510(k) number is K821154.

When did KALLESTAD QUANTIZYME THEOPHYLLINE ENZYME receive FDA 510(k) clearance?

KALLESTAD QUANTIZYME THEOPHYLLINE ENZYME received FDA 510(k) clearance on 1982-05-13, under 510(k) number K821154.

Who is the listed applicant for KALLESTAD QUANTIZYME THEOPHYLLINE ENZYME?

The FDA 510(k) record lists Jay Rau, Technical Suppprt as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KALLESTAD QUANTIZYME THEOPHYLLINE ENZYME?

The FDA product code for KALLESTAD QUANTIZYME THEOPHYLLINE ENZYME is KLS.

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Related Devices (Code: KLS)

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.