Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA Reagents

K-Number: K190088 · 2019-04-17

ApplicantInova Diagnostics, Inc.
Decision Date2019-04-17
Product CodeDHR
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA Reagents is the device name listed in this FDA 510(k) record. The listed applicant is Inova Diagnostics, Inc.. It received FDA 510(k) clearance on 2019-04-17 under 510(k) number K190088. 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 QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA Reagents?

QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA Reagents is a medical device that received FDA 510(k) clearance on 2019-04-17. The listed applicant is Inova Diagnostics, Inc.. The 510(k) number is K190088.

When did QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA Reagents receive FDA 510(k) clearance?

QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA Reagents received FDA 510(k) clearance on 2019-04-17, under 510(k) number K190088.

Who is the listed applicant for QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA Reagents?

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

What is the FDA product code for QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA Reagents?

The FDA product code for QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA Reagents is DHR.

Other records listing Inova 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.

K243979Aptiva APS IgA ReagentK223093Aptiva APS IgG Reagent; Aptiva APS IgM ReagentK213403Aptiva CTD Essential ReagentK200230Aptiva Celiac Disease IgG ReagentK193604Aptiva Celiac Disease IgA ReagentK192916NOVA Lite DAPI dsDNA Crithidia luciliae Kit

View all 16 devices →

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 CompanyK182747EliA RF IgM ImmunoassayPhadia ABK162263Optilite Rheumatoid Factor KitThe Binding Site Group , Ltd.K160070Rheumatoid Factor (RF) Kit for use on SPAPLUSThe Binding Site Group , Ltd.

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.

↑