510(k) K010893— MODIFICATION TO HYBRID CAPTURE 2 GC-ID DNA TEST, MODEL 03M92-01

Substantially Equivalent

Digene Corp.

Clearance details

Applicant: Digene Corp.
Product code: Code LSL
Advisory panel: Microbiology
Date received: 2001-03-26
Decision date: 2001-09-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gaithersburg, MD, US

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