The following data is part of a premarket notification filed by Genbio with the FDA for Immunowell Mycoplasma Pneumonia Antibody (igm) Test (3130).
Device ID | K963054 |
510k Number | K963054 |
Device Name: | IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGM) TEST (3130) |
Classification | Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp. |
Applicant | GenBio 15222 AVE. OF SCIENCE, SUITE A San Diego, CA 92128 |
Contact | Bryan Kiehl |
Correspondent | Bryan Kiehl GenBio 15222 AVE. OF SCIENCE, SUITE A San Diego, CA 92128 |
Product Code | LJZ |
CFR Regulation Number | 866.3375 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-08-06 |
Decision Date | 1997-05-05 |