The following data is part of a premarket notification filed by Flow Laboratories, Inc. with the FDA for Anairobe-tek.
| Device ID | K802626 |
| 510k Number | K802626 |
| Device Name: | ANAIROBE-TEK |
| Classification | Kit, Anaerobic Identification |
| Applicant | FLOW LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JSP |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-10-23 |
| Decision Date | 1980-11-12 |