Cleared Traditional

HYBRID CAPTURE SYSTEM CMV DNA ASSAY

K974901 · Digene Corp. · Microbiology
Sep 1998
Decision
272d
Days
Class 2
Risk

About This 510(k) Submission

K974901 is an FDA 510(k) clearance for the HYBRID CAPTURE SYSTEM CMV DNA ASSAY, a Antigen, Iha, Cytomegalovirus (Class II — Special Controls, product code LJO), submitted by Digene Corp. (Beltsville, US). The FDA issued a Cleared decision on September 29, 1998, 272 days after receiving the submission on December 31, 1997. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3175.

Submission Details

510(k) Number K974901 FDA.gov
FDA Decision Cleared SESE
Date Received December 31, 1997
Decision Date September 29, 1998
Days to Decision 272 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code LJO — Antigen, Iha, Cytomegalovirus
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3175

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