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 |