Cleared Traditional

ENDO-STAPH TEICHOIC ACID ANTIBODY KIT

K820531 · Meridian Diagnostics, Inc. · Microbiology
Apr 1982
Decision
43d
Days
Class 1
Risk

About This 510(k) Submission

K820531 is an FDA 510(k) clearance for the ENDO-STAPH TEICHOIC ACID ANTIBODY KIT, a Staphylococcus Aureus Somatic Antigens (Class I — General Controls, product code LHT), submitted by Meridian Diagnostics, Inc. (Walker, US). The FDA issued a Cleared decision on April 14, 1982, 43 days after receiving the submission on March 2, 1982. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3700.

Submission Details

510(k) Number K820531 FDA.gov
FDA Decision Cleared SESE
Date Received March 02, 1982
Decision Date April 14, 1982
Days to Decision 43 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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