The following data is part of a premarket notification filed by Granite Diagnostics, Inc. with the FDA for Brain Heart Infusion Agar W/5% Sheep Blood, Chlora.
| Device ID | K850970 |
| 510k Number | K850970 |
| Device Name: | BRAIN HEART INFUSION AGAR W/5% SHEEP BLOOD, CHLORA |
| Classification | Culture Media, Selective And Non-differential |
| Applicant | GRANITE DIAGNOSTICS, INC. 1308 RAINEY ST. Burlington, NC 27215 |
| Contact | David Preston |
| Correspondent | David Preston GRANITE DIAGNOSTICS, INC. 1308 RAINEY ST. Burlington, NC 27215 |
| Product Code | JSJ |
| CFR Regulation Number | 866.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-03-08 |
| Decision Date | 1985-03-29 |