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FDA 510(k)

EZ-BEAD THEOPHYLLINE ENZYME IMMUNOASSAY KIT

K-Number: K881257 · 1988-05-27

ApplicantImmunotech Corp.
Decision Date1988-05-27
Product CodeKLS
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

EZ-BEAD THEOPHYLLINE ENZYME IMMUNOASSAY KIT is the device name listed in this FDA 510(k) record. The listed applicant is Immunotech Corp.. It received FDA 510(k) clearance on 1988-05-27 under 510(k) number K881257. 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 EZ-BEAD THEOPHYLLINE ENZYME IMMUNOASSAY KIT?

EZ-BEAD THEOPHYLLINE ENZYME IMMUNOASSAY KIT is a medical device that received FDA 510(k) clearance on 1988-05-27. The listed applicant is Immunotech Corp.. The 510(k) number is K881257.

When did EZ-BEAD THEOPHYLLINE ENZYME IMMUNOASSAY KIT receive FDA 510(k) clearance?

EZ-BEAD THEOPHYLLINE ENZYME IMMUNOASSAY KIT received FDA 510(k) clearance on 1988-05-27, under 510(k) number K881257.

Who is the listed applicant for EZ-BEAD THEOPHYLLINE ENZYME IMMUNOASSAY KIT?

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

What is the FDA product code for EZ-BEAD THEOPHYLLINE ENZYME IMMUNOASSAY KIT?

The FDA product code for EZ-BEAD THEOPHYLLINE ENZYME IMMUNOASSAY KIT is KLS.

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Other records listing Immunotech Corp. as applicant

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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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