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FDA 510(k)

IMMPULSE SYSTEM

K-Number: K834070 · 1984-03-23

ApplicantParagon Diagnostics, Inc.
Decision Date1984-03-23
Product CodeJZT
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

IMMPULSE SYSTEM 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 1984-03-23 under 510(k) number K834070. The device is classified under product code JZT. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMMPULSE SYSTEM?

IMMPULSE SYSTEM is a medical device that received FDA 510(k) clearance on 1984-03-23. The listed applicant is Paragon Diagnostics, Inc.. The 510(k) number is K834070.

When did IMMPULSE SYSTEM receive FDA 510(k) clearance?

IMMPULSE SYSTEM received FDA 510(k) clearance on 1984-03-23, under 510(k) number K834070.

Who is the listed applicant for IMMPULSE SYSTEM?

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 SYSTEM?

The FDA product code for IMMPULSE SYSTEM is JZT.

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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 REAGENTSK840758IMMPULSE THEOPHYLLINE ASSAY REAGENTSK840847IMMPULSE TOBRAMYCIN ASSAY REAGENTSK840853IMMPULSE TBC ASSAY REAGENTS

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Related Devices (Code: JZT)

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.

K962499ZYMMUNE AUTOREADER-F FLUORESCENCE MICROPLATE READERBartels, Inc.K883349QLIA IMMUNOCHEMISTRY SYSTEMBd Becton Dickinson Vacutainer Systems PreanalyticK882677STAT-20 FLUOROMETERWeaver MedicalK864699FLUORESCENCE CONCENTRATION ANALYZER (FCA)Pandex Laboratories, Inc.K863434THE FIAX 5000 FLUOROMETERWhittaker Bioproducts, Inc.K862674PHOTON ELITE/AUTOMATED RANDOM ACCESS IM/CH SYSTEMHybritech, 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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