The following data is part of a premarket notification filed by Carr-scarborough Microbiologicals, Inc. with the FDA for Brain Heart Infusion Agar.
| Device ID | K944554 |
| 510k Number | K944554 |
| Device Name: | BRAIN HEART INFUSION AGAR |
| Classification | Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar |
| Applicant | CARR-SCARBOROUGH MICROBIOLOGICALS, INC. P.O. BOX 1328 Stone Mountain, GA 30086 |
| Contact | Leslie C Scarborough |
| Correspondent | Leslie C Scarborough CARR-SCARBOROUGH MICROBIOLOGICALS, INC. P.O. BOX 1328 Stone Mountain, GA 30086 |
| Product Code | JSO |
| CFR Regulation Number | 866.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-16 |
| Decision Date | 1994-10-04 |