The following data is part of a premarket notification filed by Gibco Laboratories Life Technologies, Inc. with the FDA for Dri-form Ureaplasma Differential Basal Agar Med.a8.
| Device ID | K855110 |
| 510k Number | K855110 |
| Device Name: | DRI-FORM UREAPLASMA DIFFERENTIAL BASAL AGAR MED.A8 |
| Classification | Culture Media, Selective And Differential |
| Applicant | GIBCO LABORATORIES LIFE TECHNOLOGIES, INC. 2801 INDUSTRIAL DR. Madison, WI 53713 |
| Contact | Gregg Burmeister |
| Correspondent | Gregg Burmeister GIBCO LABORATORIES LIFE TECHNOLOGIES, INC. 2801 INDUSTRIAL DR. Madison, WI 53713 |
| Product Code | JSI |
| CFR Regulation Number | 866.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-12-23 |
| Decision Date | 1986-01-07 |