N-ASSAY TIA TRANSFERRIN TEST KIT— 510(k) K964295

Name: FDA 510(k) clearance K964295
Creator: U.S. Food and Drug Administration
Published: 1997-06-16

Substantially Equivalent

Crestat Diagnostics, Inc.

FDA 510(k) clearance K964295 for N-ASSAY TIA TRANSFERRIN TEST KIT, Substantially Equivalent on 1997-06-16. Applicant: Crestat Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Crestat Diagnostics, Inc.
Product code: Code DDG
Device class: Class 2
Regulation: 21 CFR 866.5880
Advisory panel: Immunology
Date received: 1996-10-29
Decision date: 1997-06-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Murrieta, CA, US

Download summary PDF View on FDA.gov ↗

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