Cleared Traditional

DIAGNOSTIC KITS & KIT COMPONENTS

K812434 · Diagnostica, Inc. · Microbiology
Sep 1981
Decision
29d
Days
Class 1
Risk

About This 510(k) Submission

K812434 is an FDA 510(k) clearance for the DIAGNOSTIC KITS & KIT COMPONENTS, a Staphylococcus Aureus Somatic Antigens (Class I — General Controls, product code LHT), submitted by Diagnostica, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 23, 1981, 29 days after receiving the submission on August 25, 1981. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3700.

Submission Details

510(k) Number K812434 FDA.gov
FDA Decision Cleared SESE
Date Received August 25, 1981
Decision Date September 23, 1981
Days to Decision 29 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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