K940486

Substantially Equivalent

DIGENE DCR-1 LUMINOMETER

Applicant: Digene Diagnostics, Inc.
Product code: JJQ
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

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.