REFERENCE CHECK, CATALOG NUMBER-RCN-10— 510(k) K013708

Name: FDA 510(k) clearance K013708
Creator: U.S. Food and Drug Administration
Published: 2001-12-10

Substantially Equivalent

Precision Biologic

FDA 510(k) clearance K013708 for REFERENCE CHECK, CATALOG NUMBER-RCN-10, Substantially Equivalent on 2001-12-10. Applicant: Precision Biologic. Device class: 2.

Clearance details

Applicant: Precision Biologic
Product code: Code GIZ
Device class: Class 2
Regulation: 21 CFR 864.5425
Advisory panel: Hematology
Date received: 2001-11-08
Decision date: 2001-12-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dartmouth, N.S., CA

Download summary PDF View on FDA.gov ↗

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