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FDA 510(k)

FLUOROMATIC THEOPHYLLINE FIA

K-Number: K811856 · 1981-07-10

ApplicantBio-Rad
Decision Date1981-07-10
Product CodeLER
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

FLUOROMATIC THEOPHYLLINE FIA is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad. It received FDA 510(k) clearance on 1981-07-10 under 510(k) number K811856. 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 FLUOROMATIC THEOPHYLLINE FIA?

FLUOROMATIC THEOPHYLLINE FIA is a medical device that received FDA 510(k) clearance on 1981-07-10. The listed applicant is Bio-Rad. The 510(k) number is K811856.

When did FLUOROMATIC THEOPHYLLINE FIA receive FDA 510(k) clearance?

FLUOROMATIC THEOPHYLLINE FIA received FDA 510(k) clearance on 1981-07-10, under 510(k) number K811856.

Who is the listed applicant for FLUOROMATIC THEOPHYLLINE FIA?

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

What is the FDA product code for FLUOROMATIC THEOPHYLLINE FIA?

The FDA product code for FLUOROMATIC THEOPHYLLINE FIA is LER.

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Other records listing Bio-Rad 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.

K171061MRSASelect IIK122187VRESELECT CULTURE MEDIUMK103684VRESELECT CULTURE MEDIUMK093678PLATELIA ASPERGILLUS EIA MODEL 62793K100589MRSA SELECT - SKIN AND SOFT TISSUE WOUND SPECIMENSK081362PLATELIA LYME IGM

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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.K882570TURBOX THEOPHYLLINE ASSAYUnipath , Ltd.K864409IMMPULSE COATED TUBE THEOPHYLLINE ASSAY REAGENTSSclavo, Inc.K863475THEOFAST(TM) TEST PACKAGE3M CompanyK842585THEOPHYLLINE KIT FLUORESCENCE POLARIZA-Windsor Laboratories, 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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