DV TEST AND DVV CONFIRM— 510(k) K940490

Name: FDA 510(k) clearance K940490
Creator: U.S. Food and Drug Administration
Published: 1995-04-05

Substantially Equivalent

American Diagnostica, Inc.

FDA 510(k) clearance K940490 for DV TEST AND DVV CONFIRM, Substantially Equivalent on 1995-04-05. Applicant: American Diagnostica, Inc.. Device class: 1.

Clearance details

Applicant: American Diagnostica, Inc.
Product code: Code GIR
Device class: Class 1
Regulation: 21 CFR 864.8950
Advisory panel: Hematology
Date received: 1994-02-03
Decision date: 1995-04-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Greenwich, CT, US

Download summary PDF View on FDA.gov ↗

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