FDA 510(k) Applications for Medical Device Product Code "LJZ"
(Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp.)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K963055 | GenBio | IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGG) TEST 3120 | 05/02/1997 |
| K963054 | GenBio | IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGM) TEST (3130) | 05/05/1997 |
| K971393 | IMMUNO PROBE, INC. | MYCOPLASMA IGG ELISA TEST SYSTEM | 07/14/1997 |
| K970150 | ZEUS SCIENTIFIC, INC. | MYCOPLASMA IGG ELISA TEST SYSTEM | 06/16/1997 |
| K971503 | ZEUS SCIENTIFIC, INC. | MYCOPLASMA IGM ELISA TEST SYSTEM | 08/20/1997 |
| K984153 | ZEUS SCIENTIFIC, INC. | THE APTUS (AUTOMATED) APPLICATION OF THE MYCOPLASMA IGM ELISA TEST SYSTEM. | 01/11/1999 |
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