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FDA 510(k)

TURBOX THEOPHYLLINE ASSAY

K-Number: K882570 · 1988-11-10

ApplicantUnipath , Ltd.
Decision Date1988-11-10
Product CodeLER
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

TURBOX THEOPHYLLINE ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Unipath , Ltd.. It received FDA 510(k) clearance on 1988-11-10 under 510(k) number K882570. The device is classified under product code LER. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TURBOX THEOPHYLLINE ASSAY?

TURBOX THEOPHYLLINE ASSAY is a medical device that received FDA 510(k) clearance on 1988-11-10. The listed applicant is Unipath , Ltd.. The 510(k) number is K882570.

When did TURBOX THEOPHYLLINE ASSAY receive FDA 510(k) clearance?

TURBOX THEOPHYLLINE ASSAY received FDA 510(k) clearance on 1988-11-10, under 510(k) number K882570.

Who is the listed applicant for TURBOX THEOPHYLLINE ASSAY?

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

What is the FDA product code for TURBOX THEOPHYLLINE ASSAY?

The FDA product code for TURBOX THEOPHYLLINE ASSAY is LER.

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Other records listing Unipath , Ltd. 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.

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Related Devices (Code: LER)

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.

K942192THEOPHYLLINE FPIA REAGENT SET AND CALIBRATORSSigma Diagnostics, Inc.K905521CEDIA(R) THEOPHYLLINE ASSAY/MODIFICATIONMicrogenics Corp.K864409IMMPULSE COATED TUBE THEOPHYLLINE ASSAY REAGENTSSclavo, Inc.K863475THEOFAST(TM) TEST PACKAGE3M CompanyK842585THEOPHYLLINE KIT FLUORESCENCE POLARIZA-Windsor Laboratories, Inc.K840758IMMPULSE THEOPHYLLINE ASSAY REAGENTSParagon Diagnostics, 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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