The following data is part of a premarket notification filed by Hardy Media with the FDA for Tetrathionate Broth.
| Device ID | K870634 |
| 510k Number | K870634 |
| Device Name: | TETRATHIONATE BROTH |
| Classification | Culture Media, Enriched |
| Applicant | HARDY MEDIA 205 W.MONTECITO ST. Santa Barbara, CA 93101 |
| Contact | Jay Hardy |
| Correspondent | Jay Hardy HARDY MEDIA 205 W.MONTECITO ST. Santa Barbara, CA 93101 |
| Product Code | KZI |
| CFR Regulation Number | 866.2330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-02-13 |
| Decision Date | 1987-04-14 |