The following data is part of a premarket notification filed by Austin Biological Laboratories with the FDA for Austin Enteric System.
| Device ID | K860194 |
| 510k Number | K860194 |
| Device Name: | AUSTIN ENTERIC SYSTEM |
| Classification | Culture Media, Multiple Biochemical Test |
| Applicant | AUSTIN BIOLOGICAL LABORATORIES 6620-A MANOR RD. Austin, TX 78723 |
| Contact | Schneider Phd |
| Correspondent | Schneider Phd AUSTIN BIOLOGICAL LABORATORIES 6620-A MANOR RD. Austin, TX 78723 |
| Product Code | JSE |
| CFR Regulation Number | 866.2320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-01-22 |
| Decision Date | 1986-02-20 |