VARIANT ALPHA-THALASSEMIA SHORT PROGRAM— 510(k) K955355

Name: FDA 510(k) clearance K955355
Creator: U.S. Food and Drug Administration
Published: 1996-04-26

Substantially Equivalent

Bio-Rad

FDA 510(k) clearance K955355 for VARIANT ALPHA-THALASSEMIA SHORT PROGRAM, Substantially Equivalent on 1996-04-26. Applicant: Bio-Rad. Device class: 2.

Clearance details

Applicant: Bio-Rad
Product code: Code GKA
Device class: Class 2
Regulation: 21 CFR 864.7415
Advisory panel: Hematology
Date received: 1995-11-21
Decision date: 1996-04-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hercules, CA, US

Download summary PDF View on FDA.gov ↗

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