Cleared Traditional

MYCOPLASMA PNEUMONIAE IGG/IGM ANTIBODY TEST SYSTEM

K921556 · Medical Diagnostic Technologies, Inc. · Microbiology
Jun 1992
Decision
89d
Days
Class 1
Risk

About This 510(k) Submission

K921556 is an FDA 510(k) clearance for the MYCOPLASMA PNEUMONIAE IGG/IGM ANTIBODY TEST SYSTEM, a Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp. (Class I — General Controls, product code LJZ), submitted by Medical Diagnostic Technologies, Inc. (Augusta, US). The FDA issued a Cleared decision on June 29, 1992, 89 days after receiving the submission on April 1, 1992. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3375.

Submission Details

510(k) Number K921556 FDA.gov
FDA Decision Cleared SESE
Date Received April 01, 1992
Decision Date June 29, 1992
Days to Decision 89 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

Similar Devices — LJZ Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp.

All 12
THE APTUS (AUTOMATED) APPLICATION OF THE MYCOPLASMA IGM ELISA TEST SYSTEM.
K984153 · Zeus Scientific, Inc. · Jan 1999
MYCOPLASMA IGM ELISA TEST SYSTEM
K971503 · Zeus Scientific, Inc. · Aug 1997
MYCOPLASMA IGG ELISA TEST SYSTEM
K971393 · Immunoprobe, Inc. · Jul 1997
MYCOPLASMA IGG ELISA TEST SYSTEM
K970150 · Zeus Scientific, Inc. · Jun 1997
IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGM) TEST (3130)
K963054 · Genbio · May 1997
IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGG) TEST 3120
K963055 · Genbio · May 1997