The following data is part of a premarket notification filed by Orion Diagnostica, Inc. with the FDA for Mycoplasma Pneumoniae Antigen & Control.
| Device ID | K802934 |
| 510k Number | K802934 |
| Device Name: | MYCOPLASMA PNEUMONIAE ANTIGEN & CONTROL |
| Classification | Antigens, Cf, All, Mycoplasma Spp. |
| Applicant | ORION DIAGNOSTICA, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GSB |
| CFR Regulation Number | 866.3375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-11-19 |
| Decision Date | 1980-12-31 |