The following data is part of a premarket notification filed by Hardy Media with the FDA for Moellers Decarboxylase, Onithine.
| Device ID | K880119 |
| 510k Number | K880119 |
| Device Name: | MOELLERS DECARBOXYLASE, ONITHINE |
| Classification | Culture Media, Single Biochemical Test |
| Applicant | HARDY MEDIA 205 W.MONTECITO ST. Santa Barbara, CA 93101 |
| Contact | Jay Hardy |
| Correspondent | Jay Hardy HARDY MEDIA 205 W.MONTECITO ST. Santa Barbara, CA 93101 |
| Product Code | JSF |
| CFR Regulation Number | 866.2320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-01-06 |
| Decision Date | 1988-03-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00819398025874 | K880119 | 000 |