Cleared Traditional

STAPHYLOCOCCUS LATEX AGGLUTINATION KIT

K820683 · American Scientific Products · Microbiology
Apr 1982
Decision
34d
Days
Class 1
Risk

About This 510(k) Submission

K820683 is an FDA 510(k) clearance for the STAPHYLOCOCCUS LATEX AGGLUTINATION KIT, a Staphylococcus Aureus Somatic Antigens (Class I — General Controls, product code LHT), submitted by American Scientific Products (Mchenry, US). The FDA issued a Cleared decision on April 14, 1982, 34 days after receiving the submission on March 11, 1982. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3700.

Submission Details

510(k) Number K820683 FDA.gov
FDA Decision Cleared SESE
Date Received March 11, 1982
Decision Date April 14, 1982
Days to Decision 34 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

Similar Devices — LHT Staphylococcus Aureus Somatic Antigens

All 12
STAPHYLASE TEST
K874303 · Oxoid U.S.A., Inc. · Nov 1987
SERO-STAT R II STAPHYLOCOCCUS TEST
K863025 · Scott Laboratories, Inc. · Sep 1986
ENDO-STAPH TEICHOIC ACID ANTIBODY KIT
K820531 · Meridian Diagnostics, Inc. · Apr 1982
ACCU-STAPH
K820347 · Carr-Scarborough Microbiologicals, Inc. · Mar 1982
DIAGNOSTIC KITS & KIT COMPONENTS
K812434 · Diagnostica, Inc. · Sep 1981
GOOSE BLOOD IN ALSEVER'S, CITRATED (ACD)
K812367 · Dutchland Laboratories, Inc. · Sep 1981