ABBOTT TESTPACK(TM) D-DIMER— 510(k) K890422

Name: FDA 510(k) clearance K890422
Creator: U.S. Food and Drug Administration
Published: 1989-03-27

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K890422 for ABBOTT TESTPACK(TM) D-DIMER, Substantially Equivalent on 1989-03-27. Applicant: Abbott Laboratories. Device class: 2.

Clearance details

Applicant: Abbott Laboratories
Product code: Code GHH
Device class: Class 2
Regulation: 21 CFR 864.7320
Advisory panel: Hematology
Date received: 1989-01-26
Decision date: 1989-03-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Abbott Park, IL, US

Download summary PDF View on FDA.gov ↗

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