DIGENE DCR-1 LUMINOMETER— 510(k) K940486

Name: FDA 510(k) clearance K940486
Creator: U.S. Food and Drug Administration
Published: 1995-04-18

Substantially Equivalent

Digene Diagnostics, Inc.

FDA 510(k) clearance K940486 for DIGENE DCR-1 LUMINOMETER, Substantially Equivalent on 1995-04-18. Applicant: Digene Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: Digene Diagnostics, Inc.
Product code: Code JJQ
Device class: Class 1
Regulation: 21 CFR 862.2300
Advisory panel: Clinical Chemistry
Date received: 1994-02-02
Decision date: 1995-04-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Silver Spring, MD, US

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