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FDA 510(k)

IMMPULSE THEOPHYLLINE ASSAY REAGENTS

K-Number: K840758 · 1984-04-04

ApplicantParagon Diagnostics, Inc.
Decision Date1984-04-04
Product CodeLER
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

IMMPULSE THEOPHYLLINE ASSAY REAGENTS is the device name listed in this FDA 510(k) record. The listed applicant is Paragon Diagnostics, Inc.. It received FDA 510(k) clearance on 1984-04-04 under 510(k) number K840758. 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 IMMPULSE THEOPHYLLINE ASSAY REAGENTS?

IMMPULSE THEOPHYLLINE ASSAY REAGENTS is a medical device that received FDA 510(k) clearance on 1984-04-04. The listed applicant is Paragon Diagnostics, Inc.. The 510(k) number is K840758.

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

IMMPULSE THEOPHYLLINE ASSAY REAGENTS received FDA 510(k) clearance on 1984-04-04, under 510(k) number K840758.

Who is the listed applicant for IMMPULSE THEOPHYLLINE ASSAY REAGENTS?

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

What is the FDA product code for IMMPULSE THEOPHYLLINE ASSAY REAGENTS?

The FDA product code for IMMPULSE THEOPHYLLINE ASSAY REAGENTS is LER.

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Other records listing Paragon Diagnostics, 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.

K841162IMMPULSE GENTAMICIN ASSAY REAGENTSK841161IMMPULSE AMIKACIN ASSAY REAGENTSK840852IMMPULSE T4 ASSAY REAGENTSK840847IMMPULSE TOBRAMYCIN ASSAY REAGENTSK840853IMMPULSE TBC ASSAY REAGENTSK834070IMMPULSE SYSTEM

View all 7 devices →

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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