IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGM) TEST (3130)— 510(k) K963054

Name: FDA 510(k) clearance K963054
Creator: U.S. Food and Drug Administration
Published: 1997-05-05

Substantially Equivalent

Genbio

FDA 510(k) clearance K963054 for IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGM) TEST (3130), Substantially Equivalent on 1997-05-05. Applicant: Genbio. Device class: 1.

Clearance details

Applicant: Genbio
Product code: Code LJZ
Device class: Class 1
Regulation: 21 CFR 866.3375
Advisory panel: Microbiology
Date received: 1996-08-06
Decision date: 1997-05-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LJZ

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K984153 — THE APTUS (AUTOMATED) APPLICATION OF THE MYCOPLASMA IGM ELISA TEST SYSTEM.1999-01-11
K971503 — MYCOPLASMA IGM ELISA TEST SYSTEM1997-08-20
K971393 — MYCOPLASMA IGG ELISA TEST SYSTEM1997-07-14
K970150 — MYCOPLASMA IGG ELISA TEST SYSTEM1997-06-16
K963055 — IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGG) TEST 31201997-05-02

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K973939 — IMMUNOWELL VCA IGM TEST1998-08-10
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