The following data is part of a premarket notification filed by Remel Co. with the FDA for Ofpbl.
| Device ID | K860707 |
| 510k Number | K860707 |
| Device Name: | OFPBL |
| Classification | Culture Media, Selective And Differential |
| Applicant | REMEL CO. 12076 SANTA FE DR. Lenexa, KS 66215 |
| Contact | James G Baxendale |
| Correspondent | James G Baxendale REMEL CO. 12076 SANTA FE DR. Lenexa, KS 66215 |
| Product Code | JSI |
| CFR Regulation Number | 866.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-02-26 |
| Decision Date | 1986-03-11 |