The following data is part of a premarket notification filed by Oxoid U.s.a., Inc. with the FDA for Penase.
| Device ID | K833888 |
| 510k Number | K833888 |
| Device Name: | PENASE |
| Classification | System, Blood Culturing |
| Applicant | OXOID U.S.A., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | MDB |
| CFR Regulation Number | 866.2560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-11-09 |
| Decision Date | 1984-01-03 |