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

Substantially Equivalent

Genbio

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

Clearance details

Applicant: Genbio
Product code: Code LJZ
Advisory panel: Microbiology
Date received: 1996-08-06
Decision date: 1997-05-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

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