The following data is part of a premarket notification filed by Flow Laboratories, Inc. with the FDA for Enteric-tek.
| Device ID | K792058 |
| 510k Number | K792058 |
| Device Name: | ENTERIC-TEK |
| Classification | Kit, Identification, Enterobacteriaceae |
| Applicant | FLOW LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JSS |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-10-15 |
| Decision Date | 1980-01-11 |