Cleared Traditional

MODIFICATION TO HYBRID CAPTURE 2 GC-ID DNA TEST, MODEL 03M92-01

K010893 · Digene Corp. · Microbiology
Sep 2001
Decision
182d
Days
Class 2
Risk

About This 510(k) Submission

K010893 is an FDA 510(k) clearance for the MODIFICATION TO HYBRID CAPTURE 2 GC-ID DNA TEST, MODEL 03M92-01, a Dna-reagents, Neisseria (Class II — Special Controls, product code LSL), submitted by Digene Corp. (Gaithersburg, US). The FDA issued a Cleared decision on September 24, 2001, 182 days after receiving the submission on March 26, 2001. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3390.

Submission Details

510(k) Number K010893 FDA.gov
FDA Decision Cleared SESE
Date Received March 26, 2001
Decision Date September 24, 2001
Days to Decision 182 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code LSL — Dna-reagents, Neisseria
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3390

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