Cleared Traditional

MYCOPLASMA PNEUMONIAE ANTIBODY EIA TEST SYSTEM

K920212 · Shared Systems, Inc. · Microbiology
Aug 1992
Decision
217d
Days
Class 1
Risk

About This 510(k) Submission

K920212 is an FDA 510(k) clearance for the MYCOPLASMA PNEUMONIAE ANTIBODY EIA TEST SYSTEM, a Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp. (Class I — General Controls, product code LJZ), submitted by Shared Systems, Inc. (Martinez, US). The FDA issued a Cleared decision on August 20, 1992, 217 days after receiving the submission on January 16, 1992. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3375.

Submission Details

510(k) Number K920212 FDA.gov
FDA Decision Cleared SESE
Date Received January 16, 1992
Decision Date August 20, 1992
Days to Decision 217 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

Device Classification

Product Code LJZ — Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp.
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3375

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