Cleared Traditional

HYBRID CAPTURE II GC-ID

K981485 · Digene Corp. · Microbiology
Nov 1999
Decision
584d
Days
Class 2
Risk

About This 510(k) Submission

K981485 is an FDA 510(k) clearance for the HYBRID CAPTURE II GC-ID, a Dna-reagents, Neisseria (Class II — Special Controls, product code LSL), submitted by Digene Corp. (Beltsville, US). The FDA issued a Cleared decision on November 29, 1999, 584 days after receiving the submission on April 24, 1998. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3390.

Submission Details

510(k) Number K981485 FDA.gov
FDA Decision Cleared SESE
Date Received April 24, 1998
Decision Date November 29, 1999
Days to Decision 584 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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