The following data is part of a premarket notification filed by Oxoid U.s.a., Inc. with the FDA for Mycoplasma Supplement G.
| Device ID | K800253 | 
| 510k Number | K800253 | 
| Device Name: | MYCOPLASMA SUPPLEMENT G | 
| Classification | Supplement, Culture Media | 
| Applicant | OXOID U.S.A., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 | 
| Product Code | JSK | 
| CFR Regulation Number | 866.2450 [🔎] | 
| Decision | Substantially Equivalent (SESE) | 
| Type | Traditional | 
| 3rd Party Reviewed | No | 
| Combination Product | No | 
| Date Received | 1980-02-06 | 
| Decision Date | 1980-03-12 | 
| Device Identifier | submissionNumber | Supplement | 
|---|---|---|
| 05032384011377 | K800253 | 000 |