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FDA 510(k)

THEOFAST TEST KIT FOR QUANTITATIVE THEO

K-Number: K834244 · 1984-01-24

ApplicantAllergenetics
Decision Date1984-01-24
Product CodeKLS
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

THEOFAST TEST KIT FOR QUANTITATIVE THEO is the device name listed in this FDA 510(k) record. The listed applicant is Allergenetics. It received FDA 510(k) clearance on 1984-01-24 under 510(k) number K834244. 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 THEOFAST TEST KIT FOR QUANTITATIVE THEO?

THEOFAST TEST KIT FOR QUANTITATIVE THEO is a medical device that received FDA 510(k) clearance on 1984-01-24. The listed applicant is Allergenetics. The 510(k) number is K834244.

When did THEOFAST TEST KIT FOR QUANTITATIVE THEO receive FDA 510(k) clearance?

THEOFAST TEST KIT FOR QUANTITATIVE THEO received FDA 510(k) clearance on 1984-01-24, under 510(k) number K834244.

Who is the listed applicant for THEOFAST TEST KIT FOR QUANTITATIVE THEO?

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

What is the FDA product code for THEOFAST TEST KIT FOR QUANTITATIVE THEO?

The FDA product code for THEOFAST TEST KIT FOR QUANTITATIVE THEO is KLS.

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Other records listing Allergenetics 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.

K851512ALLERGENETICS IGE FAST TESTK842970ALLERGENTICS TOTAL IGE/THEOPHYLLINEK842969ALLERGENETICS ALLER-SPECIFIC IGE SERUMK833418CHYMOFAST TESTK834594TOTAL IGE FAST TESTK833419LABELED 125I ANTI-IGE

View all 8 devices →

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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