QUANTSTUDIO DX REAL-TIME PCR INSTRUMENT— 510(k) K123955

Name: FDA 510(k) clearance K123955
Creator: U.S. Food and Drug Administration
Published: 2013-03-08

Substantially Equivalent

Life Technologies Corporation

FDA 510(k) clearance K123955 for QUANTSTUDIO DX REAL-TIME PCR INSTRUMENT, Substantially Equivalent on 2013-03-08. Applicant: Life Technologies Corporation. Device class: 2.

Clearance details

Applicant: Life Technologies Corporation
Product code: Code OOI
Device class: Class 2
Regulation: 21 CFR 862.2570
Advisory panel: Clinical Chemistry
Date received: 2012-12-21
Decision date: 2013-03-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlsbad, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code OOI

product code OOI

Malfunction: 2,506
Other: 3
Total: 2,509

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.