The following data is part of a premarket notification filed by Bio Merieux, Inc. with the FDA for Tryptic Soy Broth W/6.5%sodium Chloride.
| Device ID | K844547 |
| 510k Number | K844547 |
| Device Name: | TRYPTIC SOY BROTH W/6.5%SODIUM CHLORIDE |
| Classification | Culture Media, Selective Broth |
| Applicant | BIO MERIEUX, INC. 421 IRMEN DR. Addison, IL 60101 |
| Contact | Micki A Maxwell |
| Correspondent | Micki A Maxwell BIO MERIEUX, INC. 421 IRMEN DR. Addison, IL 60101 |
| Product Code | JSD |
| CFR Regulation Number | 866.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-11-21 |
| Decision Date | 1985-01-16 |