REAL-TIME PCR INTERNAL CONTROL 2B SET— 510(k) K083430

Name: FDA 510(k) clearance K083430
Creator: U.S. Food and Drug Administration
Published: 2009-01-15

Substantially Equivalent

Nanogen, Inc.

FDA 510(k) clearance K083430 for REAL-TIME PCR INTERNAL CONTROL 2B SET, Substantially Equivalent on 2009-01-15. Applicant: Nanogen, Inc.. Device class: 1.

Clearance details

Applicant: Nanogen, Inc.
Product code: Code OLD
Device class: Class 1
Regulation: 21 CFR 862.1660
Advisory panel: Clinical Chemistry
Date received: 2008-11-19
Decision date: 2009-01-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

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