Cleared Traditional

STREPSLIDE

K882811 · Ncs Diagnostics, Inc. · Microbiology
Oct 1988
Decision
110d
Days
Class 1
Risk

About This 510(k) Submission

K882811 is an FDA 510(k) clearance for the STREPSLIDE, a Antigens, All Groups, Streptococcus Spp. (Class I — General Controls, product code GTY), submitted by Ncs Diagnostics, Inc. (Mississauga, L4z 1y6, CA). The FDA issued a Cleared decision on October 25, 1988, 110 days after receiving the submission on July 7, 1988. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3740.

Submission Details

510(k) Number K882811 FDA.gov
FDA Decision Cleared SESE
Date Received July 07, 1988
Decision Date October 25, 1988
Days to Decision 110 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code GTY — Antigens, All Groups, Streptococcus Spp.
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3740

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