IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGG) TEST 3120— 510(k) K963055

Name: FDA 510(k) clearance K963055
Creator: U.S. Food and Drug Administration
Published: 1997-05-02

Substantially Equivalent

Genbio

FDA 510(k) clearance K963055 for IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGG) TEST 3120, Substantially Equivalent on 1997-05-02. 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: 1997-05-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LJZ

view all

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
K963054 — IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGM) TEST (3130)1997-05-05

More clearances from Genbio

view all

K010301 — IMMUNOWELL EA (D) IGG TEST2001-06-11
K974226 — IMMUNODOT MONO-G TEST1998-09-22
K974244 — IMMUNODOT MONO-M TEST1998-09-22
K973939 — IMMUNOWELL VCA IGM TEST1998-08-10
K973940 — IMMUNOWELL EBV VCA IGG TEST1998-08-10

Data sourced from openFDA. This site is unofficial and independent of the FDA.