The following data is part of a premarket notification filed by Smith River Biologicals with the FDA for Smith River Microbiological Culture Media.
| Device ID | K923892 |
| 510k Number | K923892 |
| Device Name: | SMITH RIVER MICROBIOLOGICAL CULTURE MEDIA |
| Classification | Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar |
| Applicant | SMITH RIVER BIOLOGICALS RT. 3 BOX 191 FERRUM, VA 24088 |
| Contact | DEBORAH T FOLEY |
| Correspondent | DEBORAH T FOLEY SMITH RIVER BIOLOGICALS RT. 3 BOX 191 FERRUM, VA 24088 |
| Product Code | JSO |
| CFR Regulation Number | 866.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-04 |
| Decision Date | 1993-06-21 |