Cleared Traditional

STAPHYLASE TEST

K874303 · Oxoid U.S.A., Inc. · Microbiology
Nov 1987
Decision
17d
Days
Class 1
Risk

About This 510(k) Submission

K874303 is an FDA 510(k) clearance for the STAPHYLASE TEST, a Staphylococcus Aureus Somatic Antigens (Class I — General Controls, product code LHT), submitted by Oxoid U.S.A., Inc. (Columbia, US). The FDA issued a Cleared decision on November 6, 1987, 17 days after receiving the submission on October 20, 1987. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3700.

Submission Details

510(k) Number K874303 FDA.gov
FDA Decision Cleared SESE
Date Received October 20, 1987
Decision Date November 06, 1987
Days to Decision 17 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code LHT — Staphylococcus Aureus Somatic Antigens
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3700

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