The following data is part of a premarket notification filed by Radiation Technology, Inc. with the FDA for Microbiology Culture Media-macconkey Ag.
| Device ID | K801772 |
| 510k Number | K801772 |
| Device Name: | MICROBIOLOGY CULTURE MEDIA-MACCONKEY AG |
| Classification | Clinical Sample Concentrator |
| Applicant | RADIATION TECHNOLOGY, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JJH |
| CFR Regulation Number | 862.2310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-07-28 |
| Decision Date | 1980-08-20 |