The following data is part of a premarket notification filed by American Monitor Corp. with the FDA for Standardize Tgcl & Tgch.
| Device ID | K781376 |
| 510k Number | K781376 |
| Device Name: | STANDARDIZE TGCL & TGCH |
| Classification | Transport Systems, Anaerobic |
| Applicant | AMERICAN MONITOR CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JTX |
| CFR Regulation Number | 866.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-08-09 |
| Decision Date | 1978-09-14 |