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FDA 510(k)

DIESSE RF TEST KIT

K-Number: K854222 · 1986-02-06

ApplicantMarvic Interpharma, Inc.
Decision Date1986-02-06
Product CodeDHR
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

DIESSE RF TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Marvic Interpharma, Inc.. It received FDA 510(k) clearance on 1986-02-06 under 510(k) number K854222. The device is classified under product code DHR. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIESSE RF TEST KIT?

DIESSE RF TEST KIT is a medical device that received FDA 510(k) clearance on 1986-02-06. The listed applicant is Marvic Interpharma, Inc.. The 510(k) number is K854222.

When did DIESSE RF TEST KIT receive FDA 510(k) clearance?

DIESSE RF TEST KIT received FDA 510(k) clearance on 1986-02-06, under 510(k) number K854222.

Who is the listed applicant for DIESSE RF TEST KIT?

The FDA 510(k) record lists Marvic Interpharma, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DIESSE RF TEST KIT?

The FDA product code for DIESSE RF TEST KIT is DHR.

Related Clinical Trials

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.

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Other records listing Marvic Interpharma, 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.

K854223VES-TEC/VES-MATICK854221DIESSE CRP TEST KIT

Related Devices (Code: DHR)

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.

K192727K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2)Kamiya Biomedical CompanyK190088QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA ReagentsInova Diagnostics, Inc.K182747EliA RF IgM ImmunoassayPhadia ABK162263Optilite Rheumatoid Factor KitThe Binding Site Group , Ltd.K160070Rheumatoid Factor (RF) Kit for use on SPAPLUSThe Binding Site Group , Ltd.K102673RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEMPhadia US, 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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