Cleared Traditional

HYBRID CAPTURE II CT-ID TEST

K990023 · Digene Corp. · Microbiology
Oct 1999
Decision
293d
Days
Class 1
Risk

About This 510(k) Submission

K990023 is an FDA 510(k) clearance for the HYBRID CAPTURE II CT-ID TEST, a Dna-reagents, Chlamydia (Class I — General Controls, product code LSK), submitted by Digene Corp. (Beltsville, US). The FDA issued a Cleared decision on October 25, 1999, 293 days after receiving the submission on January 5, 1999. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3120.

Submission Details

510(k) Number K990023 FDA.gov
FDA Decision Cleared SESE
Date Received January 05, 1999
Decision Date October 25, 1999
Days to Decision 293 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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