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FDA 510(k)

IMMPULSE TBC ASSAY REAGENTS

K-Number: K840853 · 1984-04-01

ApplicantParagon Diagnostics, Inc.
Decision Date1984-04-01
Product CodeKHQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IMMPULSE TBC 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 1984-04-01 under 510(k) number K840853. The device is classified under product code KHQ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMMPULSE TBC ASSAY REAGENTS?

IMMPULSE TBC ASSAY REAGENTS is a medical device that received FDA 510(k) clearance on 1984-04-01. The listed applicant is Paragon Diagnostics, Inc.. The 510(k) number is K840853.

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

IMMPULSE TBC ASSAY REAGENTS received FDA 510(k) clearance on 1984-04-01, under 510(k) number K840853.

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

The FDA product code for IMMPULSE TBC ASSAY REAGENTS is KHQ.

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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 REAGENTSK834070IMMPULSE SYSTEM

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Related Devices (Code: KHQ)

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.

K981375ACE T UPTAKE REAGENT TU CALIBRATORSSchiapparelli Biosystems, Inc.K980088T-UPTAKE MICROPLATE EIAMonobindK970539CHIRON DIAGNOSTICS ACS:180TU PChiron Diagnostics Corp.K964308VITROS IMMUNODIAGNOSTICS PRODUCTS T3 UPTAKE REAGENT PACK (GEM.1025) AND T3 UPTAKE CALIBRATORS (GEM.C025)Johnson & Johnson Clinical Diagnostics, Inc.K961488ELECSYS T-UPTAKE ASSAYBoehringer Mannheim Corp.K954807CEDIA T UPTAKE ASSAYBoehringer Mannheim Corp.

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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