The following data is part of a premarket notification filed by Hillcrest Biologicals with the FDA for Mycoplasma Pneumoniae Cf Antigen.
| Device ID | K834338 |
| 510k Number | K834338 |
| Device Name: | MYCOPLASMA PNEUMONIAE CF ANTIGEN |
| Classification | Antigens, Cf, All, Mycoplasma Spp. |
| Applicant | HILLCREST BIOLOGICALS 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 | 1983-12-12 |
| Decision Date | 1984-02-27 |