Cleared Traditional

HYBRID CAPTURE II CT/GC TEST

K981567 · Digene Corp. · Microbiology
Feb 2000
Decision
669d
Days
Class 2
Risk

About This 510(k) Submission

K981567 is an FDA 510(k) clearance for the HYBRID CAPTURE II CT/GC TEST, a Dna-reagents, Neisseria (Class II — Special Controls, product code LSL), submitted by Digene Corp. (Beltsville, US). The FDA issued a Cleared decision on February 29, 2000, 669 days after receiving the submission on May 1, 1998. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3390.

Submission Details

510(k) Number K981567 FDA.gov
FDA Decision Cleared SESE
Date Received May 01, 1998
Decision Date February 29, 2000
Days to Decision 669 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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