Cleared Traditional

K905617 - VISI-STAPH
(FDA 510(k) Clearance)

K905617 · Connecticut Diagnostics, Ltd. · Microbiology
Mar 1991
Decision
105d
Days
Class 1
Risk

K905617 is an FDA 510(k) clearance for the VISI-STAPH, a Kit, Screening, Staphylococcus Aureus (Class I — General Controls, product code JWX), submitted by Connecticut Diagnostics, Ltd. (Danielson, US). The FDA issued a Cleared decision on March 29, 1991, 105 days after receiving the submission on December 14, 1990. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number K905617 FDA.gov
FDA Decision Cleared SESE
Date Received December 14, 1990
Decision Date March 29, 1991
Days to Decision 105 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code JWX — Kit, Screening, Staphylococcus Aureus
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2660