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FDA 510(k)

IMMPULSE AMIKACIN ASSAY REAGENTS

K-Number: K841161 · 1984-05-02

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

Device Summary

IMMPULSE AMIKACIN 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 K841161. The device is classified under product code KLQ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMMPULSE AMIKACIN ASSAY REAGENTS?

IMMPULSE AMIKACIN 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 K841161.

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

IMMPULSE AMIKACIN ASSAY REAGENTS received FDA 510(k) clearance on 1984-05-02, under 510(k) number K841161.

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

The FDA product code for IMMPULSE AMIKACIN ASSAY REAGENTS is KLQ.

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

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Related Devices (Code: KLQ)

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.

K052815QMS AMIKACIN REAGENTSSeradyn, Inc.K033884RANDOX AMIKACINRandox Laboratories, Ltd.K955570INNOFLUOR AMIKACIN ASSAY SYSTEMOxis Intl., Inc.K903100INNOFLUOR (TM) AMIKACIN REAGENT SETInnotron of Oregon, Inc.K894517FPR AMIKACIN KITColony Laboratories, Inc.K852317COBAS FP REAGEN FOR AMIKACIN & AMIKACIN CALIBRATORRoche Diagnostic Systems, 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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