Cleared Traditional

STAPHSLIDE

K874019 · Ncs Diagnostics, Inc. · Microbiology
Oct 1987
Decision
26d
Days
Class 1
Risk

About This 510(k) Submission

K874019 is an FDA 510(k) clearance for the STAPHSLIDE, a Kit, Screening, Staphylococcus Aureus (Class I — General Controls, product code JWX), submitted by Ncs Diagnostics, Inc. (Mississauga, L4z 1y6, CA). The FDA issued a Cleared decision on October 28, 1987, 26 days after receiving the submission on October 2, 1987. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number K874019 FDA.gov
FDA Decision Cleared SESE
Date Received October 02, 1987
Decision Date October 28, 1987
Days to Decision 26 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