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 LITE H-TTG SCREEN

K-Number: K073145 · 2008-02-12

Decision Date2008-02-12
Product CodeMVM
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

QUANTA LITE H-TTG SCREEN 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 2008-02-12 under 510(k) number K073145. The device is classified under product code MVM. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUANTA LITE H-TTG SCREEN?

QUANTA LITE H-TTG SCREEN is a medical device that received FDA 510(k) clearance on 2008-02-12. The listed applicant is Inova Diagnostics, Inc.. The 510(k) number is K073145.

When did QUANTA LITE H-TTG SCREEN receive FDA 510(k) clearance?

QUANTA LITE H-TTG SCREEN received FDA 510(k) clearance on 2008-02-12, under 510(k) number K073145.

Who is the listed applicant for QUANTA LITE H-TTG SCREEN?

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 LITE H-TTG SCREEN?

The FDA product code for QUANTA LITE H-TTG SCREEN is MVM.

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.

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.

View all 127 devices →

Related Devices (Code: MVM)

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.

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.

↑