The following data is part of a premarket notification filed by Remel Co. with the FDA for Bhi Agar/bhi Broth Biphasic Blood Clt.bt.
| Device ID | K802415 |
| 510k Number | K802415 |
| Device Name: | BHI AGAR/BHI BROTH BIPHASIC BLOOD CLT.BT |
| Classification | Culture Media, Non-selective And Non-differential |
| Applicant | REMEL CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JSG |
| CFR Regulation Number | 866.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-10-06 |
| Decision Date | 1980-10-31 |