Cleared Traditional

XACT NEISSERIA

K880511 · Austin Biological Laboratories · Microbiology
Aug 1988
Decision
198d
Days
Class 1
Risk

About This 510(k) Submission

K880511 is an FDA 510(k) clearance for the XACT NEISSERIA, a Kit, Identification, Neisseria Gonorrhoeae (Class I — General Controls, product code JSX), submitted by Austin Biological Laboratories (Austin, US). The FDA issued a Cleared decision on August 25, 1988, 198 days after receiving the submission on February 9, 1988. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number K880511 FDA.gov
FDA Decision Cleared SESE
Date Received February 09, 1988
Decision Date August 25, 1988
Days to Decision 198 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code JSX — Kit, Identification, Neisseria Gonorrhoeae
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2660