The following data is part of a premarket notification filed by Institute Virion Ltd. with the FDA for Mycoplasma Pneumoniae.
| Device ID | K843664 |
| 510k Number | K843664 |
| Device Name: | MYCOPLASMA PNEUMONIAE |
| Classification | Antigens, Cf, All, Mycoplasma Spp. |
| Applicant | INSTITUTE VIRION LTD. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | GSB |
| CFR Regulation Number | 866.3375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-09-17 |
| Decision Date | 1984-10-25 |