K010891

Substantially Equivalent

MODIFICATION TO HYBRID CAPTURE II CT/GC TEST, MODEL 03M90-01

Applicant: Digene Corp.
Product code: LSK
Advisory panel: Microbiology
Date received: 2001-03-26
Decision date: 2001-09-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gaithersburg, MD, US

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