PLAC TEST REAGENT KIT, MODELS 90107, 90112, 90115, 90116, 10-0112, 10-0113, 10-0115— 510(k) K101853

Name: FDA 510(k) clearance K101853
Creator: U.S. Food and Drug Administration
Published: 2011-01-03

Substantially Equivalent

Diadexus, Inc.

FDA 510(k) clearance K101853 for PLAC TEST REAGENT KIT, MODELS 90107, 90112, 90115, 90116, 10-0112, 10-0113, 10-0115, Substantially Equivalent on 2011-01-03. Applicant: Diadexus, Inc.. Device class: 2.

Clearance details

Applicant: Diadexus, Inc.
Product code: Code NOE
Device class: Class 2
Regulation: 21 CFR 866.5600
Advisory panel: Immunology
Date received: 2010-07-01
Decision date: 2011-01-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South San Francisco, CA, US

Download summary PDF View on FDA.gov ↗

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