The following data is part of a premarket notification filed by Genbio with the FDA for Immunowell Mycoplasma Pneumonia Antibody (igg) Test 3120.
| Device ID | K963055 |
| 510k Number | K963055 |
| Device Name: | IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGG) TEST 3120 |
| 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 | 1997-05-02 |