Cleared Traditional

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

K010891 · Digene Corp. · Microbiology
Sep 2001
Decision
183d
Days
Class 1
Risk

About This 510(k) Submission

K010891 is an FDA 510(k) clearance for the MODIFICATION TO HYBRID CAPTURE II CT/GC TEST, MODEL 03M90-01, a Dna-reagents, Chlamydia (Class I — General Controls, product code LSK), submitted by Digene Corp. (Gaithersburg, US). The FDA issued a Cleared decision on September 25, 2001, 183 days after receiving the submission on March 26, 2001. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3120.

Submission Details

510(k) Number K010891 FDA.gov
FDA Decision Cleared SESE
Date Received March 26, 2001
Decision Date September 25, 2001
Days to Decision 183 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code LSK — Dna-reagents, Chlamydia
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3120

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