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FDA 510(k)

VIDAS THEOPHYLLINE(THEO)

K-Number: K933258 · 1993-08-16

ApplicantBiomerieux Vitek, Inc.
Decision Date1993-08-16
Product CodeKLS
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

VIDAS THEOPHYLLINE(THEO) is the device name listed in this FDA 510(k) record. The listed applicant is Biomerieux Vitek, Inc.. It received FDA 510(k) clearance on 1993-08-16 under 510(k) number K933258. 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 VIDAS THEOPHYLLINE(THEO)?

VIDAS THEOPHYLLINE(THEO) is a medical device that received FDA 510(k) clearance on 1993-08-16. The listed applicant is Biomerieux Vitek, Inc.. The 510(k) number is K933258.

When did VIDAS THEOPHYLLINE(THEO) receive FDA 510(k) clearance?

VIDAS THEOPHYLLINE(THEO) received FDA 510(k) clearance on 1993-08-16, under 510(k) number K933258.

Who is the listed applicant for VIDAS THEOPHYLLINE(THEO)?

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

What is the FDA product code for VIDAS THEOPHYLLINE(THEO)?

The FDA product code for VIDAS THEOPHYLLINE(THEO) is KLS.

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Other records listing Biomerieux Vitek, Inc. 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.

K973819VIDAS D-DIMER (DD) ASSAYK972895VIDAS ROTAVIRUS (RTV) ASSAYK965092VIDAS ROTAVIRUS ASSAYK964887VIDAS C. DIFFICILE TOXIN A II ASSAYK955627VIDAS CHLAMYDIA BLOCKING ASSAYK962609GRAM NEGATIVE IDENTIFICATION PLUS CARD

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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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