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FDA 510(k)

IMMPULSE T4 ASSAY REAGENTS

K-Number: K840852 · 1984-04-18

ApplicantParagon Diagnostics, Inc.
Decision Date1984-04-18
Product CodeCDX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IMMPULSE T4 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 1984-04-18 under 510(k) number K840852. The device is classified under product code CDX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMMPULSE T4 ASSAY REAGENTS?

IMMPULSE T4 ASSAY REAGENTS is a medical device that received FDA 510(k) clearance on 1984-04-18. The listed applicant is Paragon Diagnostics, Inc.. The 510(k) number is K840852.

When did IMMPULSE T4 ASSAY REAGENTS receive FDA 510(k) clearance?

IMMPULSE T4 ASSAY REAGENTS received FDA 510(k) clearance on 1984-04-18, under 510(k) number K840852.

Who is the listed applicant for IMMPULSE T4 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 T4 ASSAY REAGENTS?

The FDA product code for IMMPULSE T4 ASSAY REAGENTS is CDX.

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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 REAGENTSK840758IMMPULSE THEOPHYLLINE ASSAY REAGENTSK840847IMMPULSE TOBRAMYCIN ASSAY REAGENTSK840853IMMPULSE TBC ASSAY REAGENTSK834070IMMPULSE SYSTEM

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Related Devices (Code: CDX)

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.

K961490ELECSYS T4 ASSAYBoehringer Mannheim Corp.K954312ACTIVE THYROXINE RIADiagnostic Systems Laboratories, Inc.K943416DELFIA NEONATAL THYROXINE KITWallac OYK934384AXSYM(TM) TOTAL T4Abbott LaboratoriesK932980TOTAL T4 FPIA REAGENT SET/CALIBRATOR #T-1039,T-116Sigma Diagnostics, Inc.K933426STRATUS(R) TOTAL THYROXINE(T4) FLUOR ENZYME IMMUNOBaxter 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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