The following data is part of a premarket notification filed by Medical Diagnostic Technologies, Inc. with the FDA for Mycoplasma Pneumoniae Antibody Test System.
| Device ID | K904501 |
| 510k Number | K904501 |
| Device Name: | MYCOPLASMA PNEUMONIAE ANTIBODY TEST SYSTEM |
| Classification | Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp. |
| Applicant | MEDICAL DIAGNOSTIC TECHNOLOGIES, INC. 3351 WRIGHTSBORO RD. SUITE 502 Augusta, GA 30909 |
| Contact | Harwood Stiles |
| Correspondent | Harwood Stiles MEDICAL DIAGNOSTIC TECHNOLOGIES, INC. 3351 WRIGHTSBORO RD. SUITE 502 Augusta, GA 30909 |
| Product Code | LJZ |
| CFR Regulation Number | 866.3375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-10-02 |
| Decision Date | 1991-02-26 |