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)

QUANTSTUDIO DX REAL-TIME PCR INSTRUMENT

K-Number: K123955 · 2013-03-08

ApplicantLife Technologies Corporation
Decision Date2013-03-08
Product CodeOOI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

QUANTSTUDIO DX REAL-TIME PCR INSTRUMENT is the device name listed in this FDA 510(k) record. The listed applicant is Life Technologies Corporation. It received FDA 510(k) clearance on 2013-03-08 under 510(k) number K123955. The device is classified under product code OOI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUANTSTUDIO DX REAL-TIME PCR INSTRUMENT?

QUANTSTUDIO DX REAL-TIME PCR INSTRUMENT is a medical device that received FDA 510(k) clearance on 2013-03-08. The listed applicant is Life Technologies Corporation. The 510(k) number is K123955.

When did QUANTSTUDIO DX REAL-TIME PCR INSTRUMENT receive FDA 510(k) clearance?

QUANTSTUDIO DX REAL-TIME PCR INSTRUMENT received FDA 510(k) clearance on 2013-03-08, under 510(k) number K123955.

Who is the listed applicant for QUANTSTUDIO DX REAL-TIME PCR INSTRUMENT?

The FDA 510(k) record lists Life Technologies Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for QUANTSTUDIO DX REAL-TIME PCR INSTRUMENT?

The FDA product code for QUANTSTUDIO DX REAL-TIME PCR INSTRUMENT is OOI.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Life Technologies Corporation 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.

K241806Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select PanelK233453Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR KitK191030Applied Biosystems™ 3500 Dx Genetic Analyzer and Applied Biosystems™ 3500xL Dx Genetic AnalyzerK170299Ion PGM Dx SystemK103302STEMPRO MSC SFMK100616KNOCKOUT SR MEDIUM, KNOCKOUT SR XENOFREE MEDIUM MODEL 10828, 12618

View all 7 devices →

Related Devices (Code: OOI)

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.

K243922RevogeneMeridian Bioscience, Inc.K222779RevogeneMeridian Bioscience, Inc.K220480RevogeneMeridian Bioscience, Inc.K170558revogeneGenepoc, Inc.K161495ARIES MI System, ARIES HSV 1&2 Assay Cassettes-Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD)Luminex CorporationK160517ARIES SystemLuminex Corporation

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.

↑