IMUBIND TPA ELISA, MODEL 860— 510(k) K013492

Substantially Equivalent

American Diagnostica, Inc.

FDA 510(k) clearance K013492 for IMUBIND TPA ELISA, MODEL 860, Substantially Equivalent on 2002-03-13. Applicant: American Diagnostica, Inc..

Clearance details

Applicant: American Diagnostica, Inc.
Product code: Code GGP
Advisory panel: Hematology
Date received: 2001-10-22
Decision date: 2002-03-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Greenwich, CT, US

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