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FDA 510(k)

IMMPULSE GENTAMICIN ASSAY REAGENTS

K-Number: K841162 · 1984-05-02

ApplicantParagon Diagnostics, Inc.
Decision Date1984-05-02
Product CodeLCQ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

IMMPULSE GENTAMICIN 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 1984-05-02 under 510(k) number K841162. The device is classified under product code LCQ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMMPULSE GENTAMICIN ASSAY REAGENTS?

IMMPULSE GENTAMICIN ASSAY REAGENTS is a medical device that received FDA 510(k) clearance on 1984-05-02. The listed applicant is Paragon Diagnostics, Inc.. The 510(k) number is K841162.

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

IMMPULSE GENTAMICIN ASSAY REAGENTS received FDA 510(k) clearance on 1984-05-02, under 510(k) number K841162.

Who is the listed applicant for IMMPULSE GENTAMICIN 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 GENTAMICIN ASSAY REAGENTS?

The FDA product code for IMMPULSE GENTAMICIN ASSAY REAGENTS is LCQ.

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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.

K841161IMMPULSE AMIKACIN ASSAY REAGENTSK840852IMMPULSE T4 ASSAY REAGENTSK840758IMMPULSE THEOPHYLLINE ASSAY REAGENTSK840847IMMPULSE TOBRAMYCIN ASSAY REAGENTSK840853IMMPULSE TBC ASSAY REAGENTSK834070IMMPULSE SYSTEM

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Related Devices (Code: LCQ)

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.

K972609VARIANT EXPRESS GLYCOHEMOGLOBIN PROGRAMBio-RadK955569INNOFLUOR GENTAMICIN ASSAY SYSTEMOxis Intl., Inc.K945523COBAS(R)-FP REAGENTS FOR GENTAMICIN AND COBAS(R)-FP GENTAMICIN CALIBRATORSRoche Diagnostic Systems, Inc.K943550GENTAMICIN FPIA REAGENT SET AND CALIBRATORSSigma Diagnostics, Inc.K905721OPUS GENTAMICINPb Diagnostic Systems, Inc.K904226'TDXFLX ANALYZERAbbott Laboratories

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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