The following data is part of a premarket notification filed by Miles Laboratories, Inc. with the FDA for Lab-tek Jembec G.c. Culture System.
| Device ID | K811382 |
| 510k Number | K811382 |
| Device Name: | LAB-TEK JEMBEC G.C. CULTURE SYSTEM |
| Classification | Culture Media, For Isolation Of Pathogenic Neisseria |
| Applicant | MILES LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JTY |
| CFR Regulation Number | 866.2410 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-05-15 |
| Decision Date | 1981-06-16 |