The following data is part of a premarket notification filed by Gibco Laboratories Life Technologies, Inc. with the FDA for Martin-lewis Agar W/reduced Vancomycin C0226.
| Device ID | K871541 |
| 510k Number | K871541 |
| Device Name: | MARTIN-LEWIS AGAR W/REDUCED VANCOMYCIN C0226 |
| Classification | Culture Media, For Isolation Of Pathogenic Neisseria |
| Applicant | GIBCO LABORATORIES LIFE TECHNOLOGIES, INC. 2801 INDUSTRIAL DR. Madison, WI 53713 |
| Contact | Gregg G Burmeister |
| Correspondent | Gregg G Burmeister GIBCO LABORATORIES LIFE TECHNOLOGIES, INC. 2801 INDUSTRIAL DR. Madison, WI 53713 |
| Product Code | JTY |
| CFR Regulation Number | 866.2410 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-04-20 |
| Decision Date | 1987-04-29 |