IVD CRYPTOSPORIDIUM ANTIGEN DETECTION ASSAY, MODEL CP-96— 510(k) K031059

Name: FDA 510(k) clearance K031059
Creator: U.S. Food and Drug Administration
Published: 2003-07-10

Substantially Equivalent

Ivd Research, Inc.

FDA 510(k) clearance K031059 for IVD CRYPTOSPORIDIUM ANTIGEN DETECTION ASSAY, MODEL CP-96, Substantially Equivalent on 2003-07-10. Applicant: Ivd Research, Inc.. Device class: 2.

Clearance details

Applicant: Ivd Research, Inc.
Product code: Code MHJ
Device class: Class 2
Regulation: 21 CFR 866.3220
Advisory panel: Microbiology
Date received: 2003-03-28
Decision date: 2003-07-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlsbad, CA, US

Download summary PDF View on FDA.gov ↗

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